Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer is a total knee replacement implant that resurfaces the patellofemoral and tibial articulating surfaces using a semi-constrained design, cemented in place, with polymer bearing components on a metal tray. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is JWH, regulated under 21 CFR 888.3560, and falls within the Orthopedic medical specialty. This device is an implant.
Basic Information
- Product Code
- JWH
- Device Class
- FDA class 2
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 903 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Jul 08, 2025 | Substantially Equivalent | Encore Medical, L.P. |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Jul 02, 2025 | Substantially Equivalent | Encore Medical, L.P. |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | Jun 26, 2025 | Substantially Equivalent | Maxx Orthopedics Inc. |
| K242410 | NextStep Arthropedix Total Knee System | May 08, 2025 | Substantially Equivalent | NextStep Arthropedix |
| K250889 | EXULT Knee Replacement System | Apr 17, 2025 | Substantially Equivalent | Corentec Co., Ltd. |
| K250677 | LEGION Total Knee System | Apr 02, 2025 | Substantially Equivalent | Smith & Nephew, Inc. |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Mar 24, 2025 | Substantially Equivalent | Total Joint Othopedics, Inc. |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Mar 13, 2025 | Substantially Equivalent | Maxx Orthopedics, Inc. |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | Mar 06, 2025 | Substantially Equivalent | Zimmer, Inc. |
| K244039 | MedalOne Total Knee System | Feb 28, 2025 | Substantially Equivalent | Suzhou MicroPort OrthoRecon Co., Ltd. |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Feb 18, 2025 | Substantially Equivalent | MicroPort Orthopedics Inc. |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | Feb 06, 2025 | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
| K241180 | Consensus Knee System with TiNbN | Jan 14, 2025 | Substantially Equivalent | Shalby Advanced Technologies |
| K243295 | Initia Knee System | Jan 13, 2025 | Substantially Equivalent | Kyocera Medical Technologies, Inc. |
| K243024 | Cellbrick Knee Spacer | Dec 20, 2024 | Substantially Equivalent | United Orthopedic Corporation |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | Dec 04, 2024 | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
| K243277 | Freedom® Medial Congruent Liner | Nov 19, 2024 | Substantially Equivalent | Maxx Orthopedics, Inc. |
| K242984 | BKS Revision System | Oct 25, 2024 | Substantially Equivalent | Ortho Development Corp. |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Oct 02, 2024 | Substantially Equivalent | OsteoRemedies, LLC |
| K241570 | Unity Total Knee System | Sep 23, 2024 | Substantially Equivalent | Corin USA Limited |
| K242401 | EXULT Knee Replacement System | Sep 12, 2024 | Substantially Equivalent | Corentec Co., Ltd. |
| K240683 | Rx Knee System | Sep 11, 2024 | Substantially Equivalent | Signature Orthopaedics Pty Ltd |
| K234044 | ACS® LD FB Knee System | Sep 06, 2024 | Substantially Equivalent | implantcast GmbH |
| K242046 | EXULT Knee Replacement System | Aug 01, 2024 | Substantially Equivalent | Corentec Co., Ltd. |
| K241000 | ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System; | Jul 11, 2024 | Substantially Equivalent | DePuy Ireland UC |
| K240863 | Freedom® Total Knee System | Jul 02, 2024 | Substantially Equivalent | Maxx Orthopedics Inc. |
| K240327 | UNIKO PointCloud Knee Instruments | Jun 27, 2024 | Substantially Equivalent | Unik Orthopedics, Inc. |
| K240875 | Unity Knee PS-C Tibial Insert | Jun 26, 2024 | Substantially Equivalent | Corin USA Limited |
| K240669 | ACTIFY 3D Total Knee System, ACTIFY Total Knee System | Jun 20, 2024 | Substantially Equivalent | Globus Medical, Inc |
| K240324 | EMPOWR Revision Symmetric Knee Cones | Apr 26, 2024 | Substantially Equivalent | Encore Medical, L.P. (dba Enovis) |
| K230120 | KeYi Total Knee System | Apr 19, 2024 | Substantially Equivalent | Beijing KeYi Medical Device Technology Co., Ltd. |
| K232175 | XN Knee Prosthesis System | Apr 14, 2024 | Substantially Equivalent | Beijing Chunlizhengda Medical Instruments Co. LTD |
| K234011 | AMF TT Cones | Jan 18, 2024 | Substantially Equivalent | LimaCorporate S.p.A |
| K231975 | PNK Total Knee System | Nov 21, 2023 | Substantially Equivalent | TJC Life Co., Ltd |
| K230078 | TRAX® CR Total Knee System | Nov 03, 2023 | Substantially Equivalent | Amplitude |
| K231947 | EVOLUTION® Cement Keel | Oct 31, 2023 | Substantially Equivalent | MicroPort Orthopedics Inc. |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Oct 25, 2023 | Substantially Equivalent | Ortho Development Corporation |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Sep 08, 2023 | Substantially Equivalent | Total Joint Othopedics, Inc. |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Jul 17, 2023 | Substantially Equivalent | Conformis, Inc. |
| K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Jul 17, 2023 | Substantially Equivalent | Exactech, Inc |
| K231037 | MyKnee UNI-ST | Jun 09, 2023 | Substantially Equivalent | Medacta International S.A. |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | Jun 02, 2023 | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | May 26, 2023 | Substantially Equivalent | Conformis, Inc. |
| K230537 | Klassic Knee Revision System | May 19, 2023 | Substantially Equivalent | Total Joint Othopedics, Inc. |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | May 04, 2023 | Substantially Equivalent | Smith & Nephew, Inc. |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | Apr 27, 2023 | Substantially Equivalent | Conformis Inc. |
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Apr 06, 2023 | Substantially Equivalent | Encore Medical, L.P. dba Enovis |
| K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | Mar 30, 2023 | Substantially Equivalent | Smith & Nephew, Inc. |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface | Mar 21, 2023 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K230441 | EMPOWR Stem Extender, 50mm | Mar 17, 2023 | Substantially Equivalent | Encore Medical, L.P DBA Enovis |
| K230321 | Persona Personalized Knee System | Mar 08, 2023 | Substantially Equivalent | Zimmer, Inc. |
| K222570 | COPAL knee moulds | Feb 04, 2023 | Substantially Equivalent | Heraeus Medical GmbH |
| K223650 | REMEDY Stemmed Knee Spacer | Jan 05, 2023 | Substantially Equivalent | OsteoRemedies, LLC |
| K222816 | Opulent TiNbN Coated Knee | Nov 18, 2022 | Substantially Equivalent | Meril Healthcare Pvt. Ltd. |
| K221479 | Persona Personalized Knee System | Nov 17, 2022 | Substantially Equivalent | Zimmer, Inc. |
| K223062 | World Total Knee System | Nov 04, 2022 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K222700 | Tibial baseplate, Tibial insert | Oct 06, 2022 | Substantially Equivalent | United Orthopedic Corporation |
| K222431 | b-ONER MOBIO Total Knee System | Oct 06, 2022 | Substantially Equivalent | b-ONE ORTHO, Corp. |
| K222380 | TriVerse Total Knee Replacement System | Oct 04, 2022 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Aug 26, 2022 | Substantially Equivalent | Corentec Co., Ltd. |
| K221939 | Cemented Round Patella with JRNY Pegs | Jul 26, 2022 | Substantially Equivalent | Smith & Nephew, Inc. |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Jul 26, 2022 | Substantially Equivalent | Conformis Inc. |
| K221337 | Materialise TKA Guide System | Jul 05, 2022 | Substantially Equivalent | Materialise NV |
| K211877 | Klassic Knee System | Jun 22, 2022 | Substantially Equivalent | Total Joint Orthopedics, Inc. |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | May 10, 2022 | Substantially Equivalent | Conformis Inc. |
| K220705 | MyKnee R Pin Positioners | May 04, 2022 | Substantially Equivalent | Medacta International S.A. |
| K220896 | Legion Inserts with JRNY Lock | Apr 26, 2022 | Substantially Equivalent | Smith & Nephew, Inc. |
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) | Apr 11, 2022 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K213793 | EMPOWR Revision Knee | Apr 01, 2022 | Substantially Equivalent | Encore Medical, L.P. |
| K213673 | b-ONE MOBIO Total Knee System | Jan 21, 2022 | Substantially Equivalent | b-ONE ORTHO, Corp. |
| K213381 | Physica system | Dec 17, 2021 | Substantially Equivalent | LimaCorporate S.p.A |
| K212034 | LOSPA TKR System | Dec 09, 2021 | Substantially Equivalent | Corentec Co., Ltd. |
| K212839 | Opulent TiNbN Coated Knee | Nov 16, 2021 | Substantially Equivalent | Meril Healthcare Pvt. Ltd. |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | Nov 10, 2021 | Substantially Equivalent | Conformis Inc. |
| K212129 | Persona® Personalized Knee System | Sep 28, 2021 | Substantially Equivalent | Zimmer Switzerland Manufacturing GmbH |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Sep 23, 2021 | Substantially Equivalent | Conformis Inc. |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating | Sep 16, 2021 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | Aug 25, 2021 | Substantially Equivalent | DePuy Ireland UC |
| K211671 | Journey II Mid-Level Tibial Inserts | Aug 17, 2021 | Substantially Equivalent | Smith & Nephew, Inc. |
| K210695 | CPM Medical Consultants Tibial Revision Knee System | Aug 16, 2021 | Substantially Equivalent | CPM Medical Consultants, LLC. |
| K211664 | GMK Sphere Revision | Jul 29, 2021 | Substantially Equivalent | Medacta International S.A. |
| K211602 | Klassic Knee System | Jul 23, 2021 | Substantially Equivalent | Total Joint Orthopedics, Inc. |
| K211938 | Physica LMC Knee System | Jul 13, 2021 | Substantially Equivalent | LimaCorporate |
| K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | May 18, 2021 | Substantially Equivalent | Zimmer, Inc. |
| K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | May 13, 2021 | Substantially Equivalent | Medacta International SA |
| K202924 | LinkSymphoKnee System | May 13, 2021 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) | May 12, 2021 | Substantially Equivalent | Conformis, Inc. |
| K210191 | Identity Imprint Knee Replacement System | May 06, 2021 | Substantially Equivalent | Conformis Inc. |
| K200765 | Genius / Genuin Total Knee System | May 05, 2021 | Substantially Equivalent | Biorad Medisys PVT LTD |
| K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | Apr 21, 2021 | Substantially Equivalent | United Orthopedic Corporation |
| K210483 | MOBIO Total Knee System | Apr 21, 2021 | Substantially Equivalent | b-ONE ORTHO, Corp. |
| K201611 | Apex Knee System | Apr 02, 2021 | Substantially Equivalent | OMNIlife science |
| K210551 | Persona Revision Knee System | Mar 18, 2021 | Substantially Equivalent | Zimmer, Inc. |
| K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System | Feb 17, 2021 | Substantially Equivalent | Conformis Inc. |
| K202248 | Attune Revision Sleeve LPS Femoral Adaptors | Dec 28, 2020 | Substantially Equivalent | DePuy Ireland UC |
| K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement | Dec 22, 2020 | Substantially Equivalent | Conformis Inc. |
| K202684 | GMK Total Knee System - TiNbN Coating | Dec 11, 2020 | Substantially Equivalent | Medacta International SA |
| K200912 | Freedom(R) - TiNbN Coated Knee | Nov 18, 2020 | Substantially Equivalent | Maxx Orthopedics, Inc. |
| K202429 | Mobio Total Knee System | Oct 23, 2020 | Substantially Equivalent | b-One Ortho, Corp. |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | Oct 09, 2020 | Substantially Equivalent | Total Joint Orthopedics, Inc. |
| K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) | Sep 18, 2020 | Substantially Equivalent | Medacta International SA |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | Jul 30, 2020 | Substantially Equivalent | Corentec Co., Ltd |
| K201343 | Triathlon Total KneeSystem | Jul 10, 2020 | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Jun 16, 2020 | Substantially Equivalent | Conformis, Inc. |
| K193540 | TRUMATCH Personalized Solutions | Jun 16, 2020 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K200227 | Journey II XR Knee Instrument | Jun 04, 2020 | Substantially Equivalent | Smith & Nephew, Inc |
| K200653 | AMF Revision TT Cones | May 07, 2020 | Substantially Equivalent | LimaCorporate S.p.A |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | May 07, 2020 | Substantially Equivalent | Corentec Co., Ltd |
| K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks | Apr 24, 2020 | Substantially Equivalent | Smith&Nephew, Inc. |
| K200209 | Persona Personalized Knee System | Mar 24, 2020 | Substantially Equivalent | Zimmer, Inc. |
| K200407 | LEGION Inserts with JRNY Lock | Mar 13, 2020 | Substantially Equivalent | Smith & Nephew, Inc. |
| K200075 | 3DMetal Diaphyseal Femoral Cones | Mar 13, 2020 | Substantially Equivalent | Medacta International SA |
| K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | Mar 13, 2020 | Substantially Equivalent | Conformis, Inc. |
| K193284 | Physica LMC Knee System | Jan 31, 2020 | Substantially Equivalent | Limacorporate S.p.A |
| K193057 | ATTUNE All-Polyethylene Tibia | Jan 30, 2020 | Substantially Equivalent | DePuy Ireland UC |
| K193223 | Persona Personalized Knee System | Jan 24, 2020 | Substantially Equivalent | Zimmer, Inc |
| K192507 | LOSPA II Knee System | Dec 11, 2019 | Substantially Equivalent | Corentec Co., Ltd |
| K190577 | World Knee Total Knee Systems | Nov 27, 2019 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Nov 26, 2019 | Substantially Equivalent | LimaCorporate |
| K182301 | PFC SIGMA Knee System | Nov 08, 2019 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K192084 | Madison Total Knee System | Oct 22, 2019 | Substantially Equivalent | Implanet, S.A. |
| K191765 | OMNI TiN Coated Apex Knee System | Sep 25, 2019 | Substantially Equivalent | OMNI life science, Inc. |
| K192148 | Freedom Primary PCK | Sep 05, 2019 | Substantially Equivalent | Maxx Orthopedics, Inc. |
| K191625 | Persona Revision Knee System | Sep 05, 2019 | Substantially Equivalent | Zimmer Inc. |
| K190402 | Triathlon Total Knee System-Additional Components | Aug 22, 2019 | Substantially Equivalent | Stryker Orthopaedics (aka Howmedica Osteonics Corp.) |
| K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Aug 08, 2019 | Substantially Equivalent | Conformis, Inc. |
| K191192 | SurgTech GENOLL Total Knee System | Aug 01, 2019 | Substantially Equivalent | SurgTech, Inc. |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Jul 25, 2019 | Substantially Equivalent | Osteoremedies LLC |
| K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) | Jul 18, 2019 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | Jun 20, 2019 | Substantially Equivalent | Renovis Surgical Technologies |
| K190068 | Vanguard XP Knee System | Jun 04, 2019 | Substantially Equivalent | Zimmer Inc. |
| K183533 | Unity Total Knee System | Jun 04, 2019 | Substantially Equivalent | Corin USA Limited |
| K190355 | Precision Casting Solutions Total Knee System | May 16, 2019 | Substantially Equivalent | Precision Casting Solutions, Inc. |
| K182251 | EVOLUTION NitrX Medial-Pivot Knee | May 16, 2019 | Substantially Equivalent | MircoPort Orthopedics, Inc. |
| K183583 | Vanguard Complete Knee System | May 10, 2019 | Substantially Equivalent | Zimmer Inc. |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | Apr 27, 2019 | Substantially Equivalent | Tecres SpA |
| K182872 | LINK GEMINI SL Total Knee System | Apr 03, 2019 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | Mar 29, 2019 | Substantially Equivalent | Total Joint Orthopedics, Inc. |
| K183344 | The Progressive Orthopaedic Company Total Knee System II | Mar 18, 2019 | Substantially Equivalent | The Progressive Orthopaedic Company, LLC. |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | Mar 15, 2019 | Substantially Equivalent | Total Joint Orthopedics, Inc. |
| K183225 | Stabil Orthopaedic Solutions Total Knee System | Feb 15, 2019 | Substantially Equivalent | Stabil Orthopaedic Solutions, LLC |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | Jan 28, 2019 | Substantially Equivalent | b-One Ortho Corp. |
| K182574 | Freedom Ultra-Congruent CR Tibial Liner | Jan 22, 2019 | Substantially Equivalent | Maxx Orthopedics, Inc. |
| K181338 | Imboki Knee Instrument System | Jan 17, 2019 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K182125 | EVOLUTION Stemmed CS Femur | Dec 06, 2018 | Substantially Equivalent | MicroPort Orthopedics Inc. |
| K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks | Nov 28, 2018 | Substantially Equivalent | Smith & Nephew, Inc. |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | Oct 31, 2018 | Substantially Equivalent | Ortho Development Corporation |
| K181947 | Persona Revision Knee System | Oct 25, 2018 | Substantially Equivalent | Zimmer Inc. |
| K181530 | World Total Knee System | Oct 24, 2018 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K181569 | BKS Revision Sleeves System | Oct 12, 2018 | Substantially Equivalent | Ortho Development Corporation |
| K180446 | b-ONE Total Knee System | Oct 12, 2018 | Substantially Equivalent | b-One Ortho Corp. |
| K182370 | Acculoc Total Knee System | Sep 27, 2018 | Substantially Equivalent | RootLoc Co., Ltd. |
| K181635 | GMK Sphere CR Tibial Inserts | Aug 23, 2018 | Substantially Equivalent | Medacta International SA |
| K173890 | GMK Sphere - Kinematic Alignment | Aug 23, 2018 | Substantially Equivalent | Medacta International SA |
| K181146 | ASK System | Aug 03, 2018 | Substantially Equivalent | L and K Biomed Corporation Limited |
| K180930 | EMPOWR VVC TIBIAL INSERT | Jul 09, 2018 | Substantially Equivalent | Encore Medical, L.P. |
| K180493 | A3 Total Knee System | Jun 22, 2018 | Substantially Equivalent | Beijing AK Medical Co., Ltd. |
| K180743 | Balanced Knee Revision System - Offset Junction Box | Jun 20, 2018 | Substantially Equivalent | Ortho Development Corporation |
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | May 16, 2018 | Substantially Equivalent | Conformis, Inc. |
| K180750 | World Knee System | Apr 20, 2018 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Mar 29, 2018 | Substantially Equivalent | Zimmer, Inc. |
| K170753 | Acculoc Total Knee System | Mar 23, 2018 | Substantially Equivalent | RootLoc Co., Ltd. |
| K180159 | Klassic® Knee System | Mar 09, 2018 | Substantially Equivalent | Total Joint Orthopedics, Inc. |
| K180334 | LEGION Knee System | Mar 05, 2018 | Substantially Equivalent | Smith & Nephew, Inc. |
| K173723 | EMPOWR Universal Tibial Baseplate | Mar 05, 2018 | Substantially Equivalent | Encore Medical, L.P. |
| K173445 | Materialise TKA Guide System | Feb 02, 2018 | Substantially Equivalent | Materialise NV |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | Jan 19, 2018 | Substantially Equivalent | StelKast, Inc. |
| K173884 | Unity Total Knee System | Jan 17, 2018 | Substantially Equivalent | Corin USA Limited |
| K172336 | Smith & Nephew Patient Matched Cutting Blocks | Jan 10, 2018 | Substantially Equivalent | Smith & Nephew, Inc. |
| K171269 | X-PSI Knee System | Dec 28, 2017 | Substantially Equivalent | Orthosoft Inc. (d/b/a Zimmer CAS) |
| K172936 | Destiknee Total Knee System | Nov 30, 2017 | Substantially Equivalent | Meril Healthcare Pvt. Ltd. |
| K173331 | JOURNEY II XR Knee Instruments | Nov 16, 2017 | Substantially Equivalent | Smith & Nephew, Inc. |
| K170534 | PROLIXUS TOTAL KNEE SYSTEM | Nov 09, 2017 | Substantially Equivalent | OTIS Biotech Co., Ltd. |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Oct 30, 2017 | Substantially Equivalent | Stryker Orthopaedics |
| K170106 | MyKnee PPS-Pin Positioners | Oct 20, 2017 | Substantially Equivalent | Medacta International SA |
| K170149 | 3DMetal Tibial Cones | Aug 18, 2017 | Substantially Equivalent | Medacta International SA |
| K163167 | CKS Plus Knee System | Aug 09, 2017 | Substantially Equivalent | CONSENSUS ORTHOPEDICS, INC. |
| K171389 | EVOLUTION Revision CCK System | Aug 08, 2017 | Substantially Equivalent | MicroPort Orthopedics Inc. |
| K171054 | Biomet Knee Joint Replacement Prostheses | Jul 28, 2017 | Substantially Equivalent | Biomet, Inc |
| K170613 | Genius Total Knee System | Jul 17, 2017 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K170808 | Unity Total Knee System | Jul 13, 2017 | Substantially Equivalent | Corin USA Limited |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Jun 15, 2017 | Substantially Equivalent | DePuy (Ireland) |
| K170573 | Empowr CR Knee Tibial Insert | May 31, 2017 | Substantially Equivalent | Encore Medical, L.P. |
| K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | May 22, 2017 | Substantially Equivalent | Smith & Nephew, Inc |
| K170648 | ANTHEM CR Total Knee System | May 11, 2017 | Substantially Equivalent | Smith & Nephew, Inc. |
| K171045 | Exactech® Truliant Line Extensions | Apr 28, 2017 | Substantially Equivalent | Exactech, Inc. |
| K163332 | Apex Revision Knee System | Apr 26, 2017 | Substantially Equivalent | OMNIlife science |
| K161705 | U2 Total Knee System E-XPE products | Mar 16, 2017 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K162035 | GMK Sphere | Mar 06, 2017 | Substantially Equivalent | Medacta International SA |
| K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions | Mar 01, 2017 | Substantially Equivalent | MicroPort Orthopedics, Inc. |
| K170240 | Truliant Femoral Components | Feb 23, 2017 | Substantially Equivalent | Exactech Inc |
| K161360 | U2 Total Knee System, PSA Tibial Insert | Feb 01, 2017 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K161414 | Anatomic Total Knee System | Jan 19, 2017 | Substantially Equivalent | AMPLITUDE |
| K162775 | Legion Cone System | Jan 13, 2017 | Substantially Equivalent | Smith & Nephew, Inc. |
| K160771 | Destiknee Total Knee System | Dec 19, 2016 | Substantially Equivalent | MERIL HEALTHCARE PRIVATE LIMITED |
| K160515 | PS2 Knee System | Dec 19, 2016 | Substantially Equivalent | CONSENSUS ORTHOPEDICS, INC. |
| K160157 | LOSPA Modular Knee System | Dec 01, 2016 | Substantially Equivalent | CORENTEC CO., LTD |
| K162273 | Materialise TKA Guide System | Nov 07, 2016 | Substantially Equivalent | MATERIALISE NV |
| K162422 | Klassic Knee System | Oct 28, 2016 | Substantially Equivalent | Total Joint Orthopedics, Inc. |
| K161945 | EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) | Sep 23, 2016 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K162222 | GENflex2 Total Knee System | Sep 07, 2016 | Substantially Equivalent | StelKast, Inc. |
| K160159 | Active-X Total Knee System | Sep 06, 2016 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | Jul 15, 2016 | Substantially Equivalent | CONFORMIS, INC. |
| K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Jun 14, 2016 | Substantially Equivalent | CONFORMIS, INC. |
| K160700 | ATTUNE Revision Knee System | Jun 10, 2016 | Substantially Equivalent | Depuy (Ireland) |
| K160342 | EMPOWR PS Knee System | May 19, 2016 | Substantially Equivalent | Encore Medical, L.P. |
| K152430 | All Poly Tibial Component | Apr 12, 2016 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System | Mar 25, 2016 | Substantially Equivalent | CONFORMIS, INC. |
| K153595 | Optetrak Logic Metaphyseal Cones | Mar 25, 2016 | Substantially Equivalent | EXACTECH INC |
| K160484 | Optetrak Advanced Patella | Mar 18, 2016 | Substantially Equivalent | EXACTECH INC |
| K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System | Mar 07, 2016 | Substantially Equivalent | CONFORMIS, INC. |
| K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement System | Jan 07, 2016 | Substantially Equivalent | ConforMIS, Inc. |
| K153437 | Apex Revision Knee System | Dec 21, 2015 | Substantially Equivalent | OMNILIFE SCIENCE |
| K153310 | Klassic Knee System | Dec 17, 2015 | Substantially Equivalent | TOTAL JOINT ORTHOPEDICS, INC. |
| K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments | Nov 25, 2015 | Substantially Equivalent | ZIMMER, INC. |
| K153075 | Klassic Knee System | Nov 13, 2015 | Substantially Equivalent | TOTAL JOINT ORTHOPEDICS, INC. |
| K152382 | Arthrex iBalance TKA System | Nov 12, 2015 | Substantially Equivalent | ARTHREX, INC. |
| K152008 | Physica PS Knee System | Oct 29, 2015 | Substantially Equivalent | LIMACORPORATE S.P.A. |
| K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts | Oct 27, 2015 | Substantially Equivalent | ORTHO DEVELOPMENT CORPORATION |
| K150241 | Genesis II XLPE Resurfacing Patellar Components | Oct 27, 2015 | Substantially Equivalent | Smith & Nephew, Inc. |
| K152726 | JOURNEY II XR Knee System | Oct 21, 2015 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System | Oct 21, 2015 | Substantially Equivalent | CONFORMIS, INC |
| K151266 | Physica CR Knee System | Oct 06, 2015 | Substantially Equivalent | Limacorporate S.P.A. |
| K150829 | U2 Total Knee System- Additional Sizes | Sep 25, 2015 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K152170 | Exactech Optetrak Logic Enhanced Assembly | Sep 03, 2015 | Substantially Equivalent | EXACTECH, INC. |
| K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Aug 10, 2015 | Substantially Equivalent | MATERIALISE N.V. |
| K150783 | Progressive Orthopaedic Total Knee System | Jun 23, 2015 | Substantially Equivalent | The Progressive Orthopaedic Company, LLC |
| K150496 | Total Knee Arthroplasty System | Jun 12, 2015 | Substantially Equivalent | Responsive Orthopedics LLC |
| K150890 | Exactech Optetrak Logic CC | May 29, 2015 | Substantially Equivalent | EXACTECH, INC. |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System | May 29, 2015 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, LLC |
| K143242 | Rebel 3DKNEE System | May 15, 2015 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K141934 | PHYSICA KR KNEE SYSTEM | Apr 02, 2015 | Substantially Equivalent | LIMACORPORATE S.P.A. |
| K143443 | VEGA Knee System, Columbus Total Knee System | Mar 25, 2015 | Substantially Equivalent | Aesculap Implants Systems, LLC |
| K142649 | Progressive Orthopedic Total Knee System | Mar 24, 2015 | Substantially Equivalent | The Progressive Orthopaedic Company, LLC |
| K143725 | Consensus Knee System Modular Tibial Baseplate | Mar 04, 2015 | Substantially Equivalent | Consensus Orthopedics, Inc |
| K143635 | KINETIS Total Knee System | Feb 20, 2015 | Substantially Equivalent | MAKO SURGICAL |
| K150105 | Klassic Knee System-Sombrero Patella | Feb 17, 2015 | Substantially Equivalent | TOTAL JOINT ORTHOPEDICS, INC. |
| K143226 | Visionaire Disposable Instruments | Feb 12, 2015 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K143192 | Vanguard 360 Revision Knee System | Feb 12, 2015 | Substantially Equivalent | Biomet, Inc. |
| K142933 | Biomet Tibial trays | Dec 23, 2014 | Substantially Equivalent | BIOMET, INC. |
| K142807 | ANTHEM PS Total Knee System | Dec 22, 2014 | Substantially Equivalent | Smith & Nephew, Inc. |
| K142787 | Zimmer Persona Personalized Knee System | Dec 22, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System | Dec 11, 2014 | Substantially Equivalent | ConforMIS Inc. |
| K142388 | Neo Total Knee System | Dec 05, 2014 | Substantially Equivalent | New Era Orthopedics, LLC |
| K142069 | GMK EXTENSION | Dec 02, 2014 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K143106 | VEGA Knee System | Nov 21, 2014 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, LLC |
| K143047 | Arthrex iBalance Patella Implant, Dome | Nov 19, 2014 | Substantially Equivalent | ARTHREX, INC. |
| K140222 | SAIPH KNEE SYSTEM | Nov 17, 2014 | Substantially Equivalent | MATORTHO |
| K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | Nov 14, 2014 | Substantially Equivalent | CONFORMIS, INC. |
| K141471 | JOURNEY II XR KNEE SYSTEM | Nov 14, 2014 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments | Nov 07, 2014 | Substantially Equivalent | MICROPORT ORTHOPEDICS INC. |
| K141585 | SMITH & NEPHEW DISPOSABLE FIN PUNCH | Aug 21, 2014 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K140826 | GMK SPHERE EXTENSION | Jul 15, 2014 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K133919 | CONSENSUS VITALITE TIBIAL INSERT | Jul 14, 2014 | Substantially Equivalent | CONSENSUS ORTHOPEDICS, INC. |
| K140830 | EXPRT REVISION KNEE | Jul 11, 2014 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K140902 | E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG | Jul 03, 2014 | Substantially Equivalent | BIOMET, INC. |
| K140833 | ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM | Jun 30, 2014 | Substantially Equivalent | CONFORMIS, INC. |
| K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED | Jun 16, 2014 | Substantially Equivalent | UNITED ORTHOPEDIC CORP. |
| K140555 | JOURNEY II BCS CONSTRAINED INSERTS | May 29, 2014 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | May 27, 2014 | Substantially Equivalent | CONFORMIS, INC. |
| K140027 | ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER | May 22, 2014 | Substantially Equivalent | MATERIALISE N.V. |
| K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION | May 16, 2014 | Substantially Equivalent | TOTAL JOINT ORTHOPEDICS, INC. |
| K133560 | ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM | Mar 28, 2014 | Substantially Equivalent | CONFORMIS, INC. |
| K140452 | VEGA KNEE SYSTEM | Mar 25, 2014 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS |
| K132752 | ULTRACONGRUENT INSERT | Mar 13, 2014 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K133854 | ARTHREX IBALANCE TKA SYSTEM | Feb 27, 2014 | Substantially Equivalent | ARTHREX, INC. |
| K133162 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA | Feb 25, 2014 | Substantially Equivalent | MATERIALISE N.V. |
| K131481 | FREEDOM PCK COMPONENTS | Feb 21, 2014 | Substantially Equivalent | MAXX ORTHOPEDICS, INC. |
| K133449 | KASM KNEE ARTICULATING SPACER MOLDS | Feb 18, 2014 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K133737 | ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION | Feb 04, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K131864 | U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT | Jan 15, 2014 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K133256 | ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | Jan 09, 2014 | Substantially Equivalent | CONFORMIS, INC. |
| K133630 | GMK SHORT STEM | Dec 20, 2013 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K133342 | ARTHREX IBALANCE TKA SYSTEM | Dec 17, 2013 | Substantially Equivalent | ARTHREX, INC. |
| K130708 | SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS | Dec 11, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K131116 | U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER | Oct 30, 2013 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K131679 | EVOLUTION MP ADAPTIVE PS TIBIAL INSERT | Oct 23, 2013 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K132161 | OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS | Oct 11, 2013 | Substantially Equivalent | EXACTECH, INC. |
| K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA | Oct 11, 2013 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K131472 | APEX KNEE MODULAR TIBIA SYSTEM | Oct 08, 2013 | Substantially Equivalent | OMNI LIFE SCIENCE, INC. |
| K131368 | NEO KNEE SYSTEM | Oct 03, 2013 | Substantially Equivalent | PIPELINE ORTHOPEDICS |
| K132046 | PIPELINE KNEE SYSTEM | Sep 23, 2013 | Substantially Equivalent | PIPELINE ORTHOPEDICS |
| K131398 | NOVOKNEE TOTAL KNEE SYSTEM | Sep 16, 2013 | Substantially Equivalent | NOVOSOURCE INC |
| K131409 | CAS PSI KNEE SYSTEM | Sep 13, 2013 | Substantially Equivalent | ORTHOSOFT, INC. |
| K131310 | GMK FULL PE TIBIAL COMPONENTS | Aug 22, 2013 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM | Aug 05, 2013 | Substantially Equivalent | STELKAST COMPANY |
| K123721 | GMK REVISION EXTENSION | Jul 26, 2013 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K131467 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Jul 18, 2013 | Substantially Equivalent | CONFORMIS, INC. |
| K131019 | ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM | May 24, 2013 | Substantially Equivalent | CONFORMIS, INC. |
| K123692 | PIPELINE KNEE SYSTEM | May 24, 2013 | Substantially Equivalent | PIPELINE ORTHOPEDICS |
| K130084 | MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM | May 03, 2013 | Substantially Equivalent | TGM MEDICAL, INC. |
| K123159 | SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS | May 03, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K122500 | NEO PS KNEE SYSTEM | May 03, 2013 | Substantially Equivalent | PIPELINE ORTHOPEDICS |
| K130673 | LOSPA TOTAL KNEE REPLACEMENT SYSTEM | Apr 15, 2013 | Substantially Equivalent | CORENTEC CO., LTD |
| K123339 | TK1 TOTAL KNEE SYSTEM | Apr 11, 2013 | Substantially Equivalent | NOVOSOURCE INC |
| K122239 | FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING | Apr 11, 2013 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K123457 | BALANCED KNEE SYSTEM HIGH FLEX PS | Mar 22, 2013 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K123687 | OPTETRAK LOGIC POROUS FEMORAL COMPONENT | Mar 20, 2013 | Substantially Equivalent | EXACTECH, INC. |
| K130143 | PERSONA NATURAL TIBIA BASEPLATES | Feb 22, 2013 | Substantially Equivalent | ZIMMER, INC. |
| K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P | Feb 14, 2013 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K122183 | AUGMENT AND SCREW, PSA TYPE | Feb 05, 2013 | Substantially Equivalent | UNITED ORTHOPEDIC CORP. |
| K122870 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Jan 14, 2013 | Substantially Equivalent | CONFORMIS, INC. |
| K123342 | OPTETRAK LOGIC CRC TIBIAL INSERT | Jan 10, 2013 | Substantially Equivalent | EXACTECH, INC. |
| K122991 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Dec 20, 2012 | Substantially Equivalent | CONFORMIS, INC. |
| K122975 | GKS PRIME FLEX CR TOTAL KNEE SYSTEM | Dec 20, 2012 | Substantially Equivalent | PERMEDICA |
| K120955 | COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM | Dec 17, 2012 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, LLC |
| K121640 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM | Dec 05, 2012 | Substantially Equivalent | MATERIALISE N.V. |
| K122765 | PERSONA NATURAL TIBIA BASEPLATES | Nov 09, 2012 | Substantially Equivalent | ZIMMER INC. |
| K122985 | COLUMBUS REVISION KNEE SYSTEM | Oct 26, 2012 | Substantially Equivalent | AESCULAP IMPLANT SYSTEM, INC. |
| K122232 | GMK NARROW | Sep 28, 2012 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K122033 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Sep 27, 2012 | Substantially Equivalent | CONFORMIS, INC. |
| K113060 | UNITY TOATAL KNEE SYSTEM | Sep 10, 2012 | Substantially Equivalent | CORIN U.S.A. |
| K121443 | JOURNEY II CR KNEE SYSTEM | Aug 13, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K121879 | VEGA KNEE SYSTEM | Jul 27, 2012 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS |
| K121835 | DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE | Jul 20, 2012 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K121416 | GMK SPHERE | Jul 20, 2012 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K111785 | FREEDOM(R) STEMMED TIBIAL COMPONENTS | Jun 29, 2012 | Substantially Equivalent | MAXX ORTHOPEDICS, INC. |
| K120790 | GMK - LINE EXTENSION | Jun 08, 2012 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K121307 | OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ | May 31, 2012 | Substantially Equivalent | EXACTECH, INC. |
| K120698 | GENESIS II PS NON-MODULAR FEMORAL COMPONENT | May 18, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K121149 | VANGUARD SSK 360 REVISION KNEE SYSTEM | May 16, 2012 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K120507 | UNITED U2 FEMORAL COMPONENT, PS, #7 | May 04, 2012 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K121037 | LOSPA TIBIAL BASE PLATE | May 03, 2012 | Substantially Equivalent | CORENTEC CO., LTD |
| K120313 | NEO CR KNEE SYSTEM | Apr 20, 2012 | Substantially Equivalent | PIPELINE ORTHOPEDICS |
| K120316 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Apr 19, 2012 | Substantially Equivalent | CONFORMIS, INC. |
| K113829 | ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE | Apr 02, 2012 | Substantially Equivalent | MATERIALISE N.V. |
| K113369 | ZIMMER PERSONA KNEE SYSTEM | Mar 27, 2012 | Substantially Equivalent | ZIMMER INC. |
| K113122 | PIPELINE CR PRIMARY KNEE SYSTEM | Mar 20, 2012 | Substantially Equivalent | PIPELINE ORTHOPEDICS |
| K113550 | VANGUARD COMPLETE KNEE SYSTEM | Feb 29, 2012 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K112891 | APEX REVISION KNEE SYSTEMS | Feb 29, 2012 | Substantially Equivalent | OMNI LIFE SCIENCE, INC. |
| K113482 | JOURNEY II DEEP DISHED ARTICULAR INSERTS | Feb 27, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K110404 | EAUM TOTAL KNEE SYSTEM | Feb 16, 2012 | Substantially Equivalent | CORENTEC CO., LTD |
| K113378 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Feb 15, 2012 | Substantially Equivalent | CONFORMIS, INC. |
| K120068 | CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) | Feb 03, 2012 | Substantially Equivalent | CONFORMIS, INC. |
| K112906 | KLASSIC KNEE SYSTEM | Feb 01, 2012 | Substantially Equivalent | TOTAL JOINT ORTHOPEDICS, INC. |
| K113571 | GMK RESUFACING PATELLA SIZE 4 | Jan 27, 2012 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K112941 | LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS | Dec 20, 2011 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K112780 | CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Dec 15, 2011 | Substantially Equivalent | CONFORMIS, INC. |
| K113325 | EVOLUTION MP ADAPTIVE CS INSERT | Dec 09, 2011 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K112285 | MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... | Nov 04, 2011 | Substantially Equivalent | TGM MEDICAL, INC. |
| K111492 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS | Oct 13, 2011 | Substantially Equivalent | MATERIALISE N.V. |
| K111711 | JOURNEY II BCS KNEE SYSTEM | Sep 16, 2011 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K110397 | TRUMATCH PERSONALIZED SOLUTIONS | Aug 16, 2011 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K103733 | UNITED U2 XPE TOTAL KNEE SYSTEM | Aug 02, 2011 | Substantially Equivalent | UNITED ORTHOPEDIC CORPORATION |
| K111400 | OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT | Jul 28, 2011 | Substantially Equivalent | EXACTECH, INC. |
| K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA | Jul 13, 2011 | Substantially Equivalent | OMNILIFE SCIENCE INC. |
| K111184 | APEX PS KNEE SYSTEM - PS-C INSERT | Jun 22, 2011 | Substantially Equivalent | OMNILIFE SCIENCE INC. |
| K111283 | GMK REVISION HYBRID LINERS | May 27, 2011 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K094013 | HLS KNEETEC SYSTEM | May 05, 2011 | Substantially Equivalent | TORNIER |
| K110837 | REVISION PROTHESIS | Apr 22, 2011 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K110547 | OPTERTRAK LOGIC PSC TIBIAL INSERT | Apr 14, 2011 | Substantially Equivalent | EXACTECH SARASOTA |
| K102578 | APEX PS KNEE SYSTEM | Mar 25, 2011 | Substantially Equivalent | OMNI LIFE SCIENCE, INC. |
| K103837 | BALANCED KNEE SYSTEM REVISION OFFSET TIBIA | Mar 24, 2011 | Substantially Equivalent | ORTHO DEVELOPMENT |
| K103170 | GMK REVISION KNEE SC LINERS | Mar 24, 2011 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K100370 | SYMMETRIC TOTAL KNEE AGUMENTS | Mar 07, 2011 | Substantially Equivalent | SIGNAL MEDICAL CORP. |
| K102580 | VANGUARD REMOVABLE MOLDED POLY TIBIA | Mar 03, 2011 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K110362 | VANGUARD ASYMMETRICAL PATELLAR COMPONENT | Feb 28, 2011 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K102125 | PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS | Feb 23, 2011 | Substantially Equivalent | BIOMET, INC. |
| K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES | Feb 02, 2011 | Substantially Equivalent | MATERIALISE N.V. |
| K103117 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM | Jan 07, 2011 | Substantially Equivalent | CONFORMIS, INC. |
| K102380 | EVOLUTION MP TOTAL KNEE SYSTEM | Jan 07, 2011 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K102367 | OPTIGEN TOTAL KNEE SYSTEM | Dec 08, 2010 | Substantially Equivalent | U&I CORP. |
| K093293 | VANGUARD 360 REVISION KNEE SYSTEM | Oct 22, 2010 | Substantially Equivalent | BIOMET, INC. |
| K100391 | DEPUY UNIVERSAL GRIPTION TF CONES | Sep 29, 2010 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K101994 | APEX KNEE MODULAR TIBIA SYSTEM | Sep 28, 2010 | Substantially Equivalent | OMNLIFE SCIENCE |
| K102437 | GMK REVISION KNEE SYSTEM | Sep 24, 2010 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K094050 | ITOTAL CR KNEE REPLACEMENT SYSTEM | Sep 16, 2010 | Substantially Equivalent | CONFORMIS, INC. |
| K101499 | JOURNEY CR KNEE SYSTEM | Aug 26, 2010 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K101981 | OPTETRAK LOGIC COMBINATION TIBIAL TRAY | Aug 02, 2010 | Substantially Equivalent | EXACTECH, INC. |
| K101281 | VEGA KNEE SYSTEM | Jul 30, 2010 | Substantially Equivalent | AESCULAP IMPLANT SYSTEM, INC. |
| K101032 | CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX | Jul 08, 2010 | Substantially Equivalent | CARDO MEDICAL, INC |
| K100542 | CONSENSUS REVISION KNEE SYSTEM | Jun 24, 2010 | Substantially Equivalent | Consensus Orthopedics, Inc |
| K100900 | MOTIVATION KNEE SYSTEM | Jun 18, 2010 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K100981 | UNITED STEM, PSA TYPE | Jun 14, 2010 | Substantially Equivalent | UNITED ORTHOPEDIC CORP. |
| K093746 | VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM | Apr 14, 2010 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K093806 | MYKNEE CUTTING BLOCKS | Apr 08, 2010 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K094017 | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 | Mar 05, 2010 | Substantially Equivalent | OMNI LIFE SCIENCE, INC. |
| K093552 | EVOLUTION MP TOTAL KNEE SYSTEM | Mar 04, 2010 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K093567 | ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM | Feb 05, 2010 | Substantially Equivalent | ANOVA IMPLANT SOLUTIONS, LLC |
| K093360 | OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T | Jan 11, 2010 | Substantially Equivalent | EXACTECH, INC. |
| K092803 | CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT | Dec 23, 2009 | Substantially Equivalent | CARDO MEDICAL CORP. |
| K091263 | ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) | Nov 19, 2009 | Substantially Equivalent | MATERIALISE N.V. |
| K090705 | BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT | Oct 09, 2009 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K091014 | JOURNEY BCS KNEE SYSTEM | Sep 29, 2009 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K091280 | FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT | Sep 25, 2009 | Substantially Equivalent | MAXX ORTHOPEDICS, INC. |
| K092201 | ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE | Aug 20, 2009 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K090988 | GMK TOTAL KNEE SYSTEM | Jul 10, 2009 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K083772 | COLUMBUS REVISION KNEE SYSTEM | Jun 04, 2009 | Substantially Equivalent | AESCULAP IMPLANT SYSTEM, INC. |
| K090411 | FREEDOM METAL BACKED TIBIAL COMPONENT | Apr 07, 2009 | Substantially Equivalent | MAXX ORTHOPEDICS, INC. |
| K081400 | FANNING-PAPPAS MODULAR KNEE BEARING | Feb 20, 2009 | Substantially Equivalent | ENDOTEC, INC. |
| K082019 | FREEDOM TOTAL KNEE SYSTEM | Feb 06, 2009 | Substantially Equivalent | MAXX ORTHOPEDICS, INC. |
| K082424 | UNITED U2 TOTAL KNEE SYSTEM | Dec 16, 2008 | Substantially Equivalent | UNITED ORTHOPEDIC CORP. |
| K082358 | SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY | Nov 25, 2008 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K082500 | DEPUY SIGMA CR-F FEMORAL COMPONENT | Nov 18, 2008 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K082826 | VANGUARD CR STEM HOUSINGS | Oct 24, 2008 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K081023 | EVOLIS TOTAL KNEE SYSTEM | Oct 22, 2008 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K081127 | ACCIN TOTAL KNEE SYSTEM | Oct 17, 2008 | Substantially Equivalent | ACCELERATED INNOVATION, LLC |
| K082469 | UNITED U2 PATELLA | Sep 26, 2008 | Substantially Equivalent | UNITED ORTHOPEDIC CORP. |
| K082022 | OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ | Sep 02, 2008 | Substantially Equivalent | EXACTECH, INC. |
| K080199 | SYMMETRIC TOTAL KNEE SYSTEM | Jul 03, 2008 | Substantially Equivalent | SIGNAL MEDICAL CORPORATION |
| K080528 | E-POLY TIBIAL BEARINGS | Jun 17, 2008 | Substantially Equivalent | BIOMET ORTHOPEDICS, INC. |
| K081458 | PROVEN STEM EXTENDER | Jun 06, 2008 | Substantially Equivalent | STELKAST COMPANY |
| K062274 | SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 | May 22, 2008 | Substantially Equivalent | TECRES SPA |
| K080936 | CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS | May 12, 2008 | Substantially Equivalent | CONFORMIS, INC. |
| K080204 | VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS | Mar 20, 2008 | Substantially Equivalent | BIOMET, INC. |
| K073286 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM | Mar 07, 2008 | Substantially Equivalent | ZIMMER, INC. |
| K073602 | MODIFICATION TO: APEX KNEE SYSTEM | Feb 14, 2008 | Substantially Equivalent | OMNLIFE SCIENCE |
| K073529 | DEPUY SIGMA PS FEMORAL COMPONENTS | Jan 24, 2008 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K063686 | DEPUY LPS DISTAL FEMORAL COMPONENT | Dec 20, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K072531 | LEGION STEM WITH HOLES | Dec 06, 2007 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K072858 | TC-PLUS PRIMARY KNEE SYSTEM | Nov 20, 2007 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K072336 | REGENEREX POROUS TITANIUM SLEEVE AUGMENTS | Nov 05, 2007 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K072221 | MODIFICATION TO TRIATHLON TS KNEE SYSTEM | Oct 15, 2007 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K071071 | CROSSLINKED POLYETHYLENE ARTICULAR INSERTS | Sep 19, 2007 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K071499 | COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY | Sep 14, 2007 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, INC. |
| K072281 | NEXGEN PROLONG ALL-POLY PATELLA | Sep 06, 2007 | Substantially Equivalent | ZIMMER, INC. |
| K070981 | SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) | Aug 21, 2007 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, INC. |
| K071991 | MODIFICATION TO SCORPIO NRG KNEE SYSTEM | Aug 15, 2007 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K071738 | EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER | Aug 15, 2007 | Substantially Equivalent | EXACTECH, INC. |
| K071220 | COLUMBUS TOTAL KNEE SYSTEM AS | Jun 01, 2007 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, INC. |
| K070095 | TRIATHLON TS KNEE SYSTEM | Jun 01, 2007 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K063633 | DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES | Mar 02, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K063423 | TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT | Jan 22, 2007 | Substantially Equivalent | HOWMEDICA OSTEONICS |
| K063732 | MICROPLASTY TIBIAL TRAYS | Jan 18, 2007 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K063211 | PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT | Jan 18, 2007 | Substantially Equivalent | STELKAST COMPANY |
| K063406 | ENCORE KNEE SYSTEM IFU | Jan 08, 2007 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K062768 | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL | Oct 13, 2006 | Substantially Equivalent | ZIMMER, INC. |
| K061340 | 23 MM SINGLE-PEG PATELLA COMPONENT | Sep 25, 2006 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K052687 | CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM | Aug 31, 2006 | Substantially Equivalent | CONFORMIS, INC. |
| K062037 | TRIATHLON LOW PROFILE TIBIAL TRAY | Aug 03, 2006 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K061882 | OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES | Aug 01, 2006 | Substantially Equivalent | ZIMMER, INC. |
| K060569 | BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM | Jul 06, 2006 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K060192 | APEX KNEE SYSTEM | Jun 15, 2006 | Substantially Equivalent | OMNI LIFE SCIENCE, INC. |
| K060722 | NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT | May 26, 2006 | Substantially Equivalent | ZIMMER, INC. |
| K060525 | VANGUARD REMOVABLE MOLDED POLY TIBIA | May 25, 2006 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K053579 | COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE | May 17, 2006 | Substantially Equivalent | AESCULAP, INC. |
| K060742 | LEGION COBALT CHROME REVISION KNEE SYSTEM | May 03, 2006 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K060370 | NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS | Apr 28, 2006 | Substantially Equivalent | ZIMMER, INC. |
| K060515 | DEPUY PFC SIGMA KNEE PROSTHESIS | Mar 23, 2006 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K051640 | U2 TOTAL KNEE SYSTEM | Mar 01, 2006 | Substantially Equivalent | UNITED ORTHOPEDIC CORP. |
| K053390 | COLUMBUS (CR) TOTAL KNEE SYSTEM | Feb 06, 2006 | Substantially Equivalent | AESCULAP, INC. |
| K053514 | TRIATHLON TOTAL KNEE SYSTEM | Jan 26, 2006 | Substantially Equivalent | STRYKER ORTHOPAEDICS |
| K052879 | NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS | Nov 22, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K051976 | PROVEN REVISION MODULAR TIBIAL TRAY | Oct 17, 2005 | Substantially Equivalent | STELKAST COMPANY |
| K051977 | SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS | Oct 12, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K051756 | MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ | Jul 27, 2005 | Substantially Equivalent | ZIMMER TRABECULAR |
| K051229 | PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT | Jul 20, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K050210 | DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES | Jul 19, 2005 | Substantially Equivalent | BIOMET, INC. |
| K051146 | TRIATHLON KNEE SYSTEM | Jul 13, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K050723 | MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS | Apr 20, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K050539 | SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT | Mar 29, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K042515 | SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE | Mar 14, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K041825 | SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT | Mar 11, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K043101 | NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS | Mar 07, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K043440 | SMITH & NEPHEW, INC. REVISION KNEE SYSTEM | Feb 18, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K042757 | VANGUARD SSK KNEE SYSTEM | Feb 11, 2005 | Substantially Equivalent | BIOMET, INC. |
| K042343 | SCORPIO NRG KNEE SYSTEM | Feb 09, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K042993 | TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT | Jan 12, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K033260 | AEQUOS | Dec 07, 2004 | Substantially Equivalent | AAP IMPLANTATE AG |
| K042883 | SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT | Nov 23, 2004 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K042271 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES | Oct 13, 2004 | Substantially Equivalent | ZIMMER, INC. |
| K040630 | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ | Sep 30, 2004 | Substantially Equivalent | IMPLEX CORP. |
| K041591 | SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS | Sep 23, 2004 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K041085 | LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY | Jul 22, 2004 | Substantially Equivalent | DEPUY, INC. |
| K040281 | LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) | Jul 09, 2004 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K041466 | TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) | Jul 01, 2004 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K041106 | REVISION KNEE SYSTEM | Jul 01, 2004 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K033959 | LPS | Jul 01, 2004 | Substantially Equivalent | DEPUY, INC. |
| K040964 | SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS | May 28, 2004 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K032522 | TECRES SPACER-K TEMPORARY KNEE PROSTHESIS | May 28, 2004 | Substantially Equivalent | EXACTECH, INC. |
| K041046 | MAXIM ACCEL (VANGUARD) PS+ BEARINGS | May 21, 2004 | Substantially Equivalent | BIOMET, INC. |
| K040267 | TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE | May 05, 2004 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K040770 | VANGUARD PATELLA COMPONENTS | Apr 22, 2004 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K040166 | DEPUY SIGMA XLK TIBIAL INSERTS | Feb 23, 2004 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K033883 | OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI | Feb 13, 2004 | Substantially Equivalent | EXACTECH, INC. |
| K033272 | DEPUY SIGMA TIBIAL INSERTS | Feb 05, 2004 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K033890 | ADVANCE DOUBLE HIGH INSERT | Jan 15, 2004 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K033342 | SCORPIO KNEE SYSTEM - TIBIAL INSERTS | Jan 15, 2004 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS | Jan 08, 2004 | Substantially Equivalent | IMPLEX CORP. |
| K032950 | GEM INSET PATELLAR COMPONENT | Dec 19, 2003 | Substantially Equivalent | KINAMED, INC. |
| K032829 | SCORPIO LOW PROFILE TIBIAL TRAY | Dec 10, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K030978 | SCORPIO NRG KNEE SYSTEM | Nov 20, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K031901 | PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT | Oct 10, 2003 | Substantially Equivalent | STELKAST COMPANY |
| K032079 | HLS NOETOS SYSTEM | Oct 02, 2003 | Substantially Equivalent | TORNIER |
| K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | Sep 26, 2003 | Substantially Equivalent | DEPUY, INC. |
| K032606 | OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS | Sep 23, 2003 | Substantially Equivalent | EXACTECH, INC. |
| K032479 | HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS | Sep 04, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K031729 | TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM | Sep 02, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K032295 | GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT | Aug 21, 2003 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K030367 | COLUMBUS (PS) | Aug 21, 2003 | Substantially Equivalent | AESCULAP, INC. |
| K032215 | VKS/TC-PLUS REVISION KNEE | Aug 08, 2003 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K031201 | ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM | Jul 15, 2003 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K031183 | TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE | Jul 14, 2003 | Substantially Equivalent | CENTERPULSE ORTHOPEDICS, INC. |
| K030686 | OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT | Apr 02, 2003 | Substantially Equivalent | EXACTECH, INC. |
| K030577 | PROVEN MODULAR TIBIAL TRAY | Mar 25, 2003 | Substantially Equivalent | STELKAST COMPANY |
| K030301 | UNICONDYLAR FEMORAL COMPONENT | Feb 25, 2003 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K023724 | DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT | Feb 03, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K023546 | MAXIM ACCEL KNEE SYSTEM | Jan 17, 2003 | Substantially Equivalent | BIOMET, INC. |
| K023528 | NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE | Jan 17, 2003 | Substantially Equivalent | CENTERPLUS ORTHOPEDICS, INC |
| K024161 | NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS | Jan 15, 2003 | Substantially Equivalent | IMPLEX CORP. |
| K024037 | NARROW ASCENT INTERLOK FEMORAL COMPONENTS | Dec 30, 2002 | Substantially Equivalent | BIOMET, INC. |
| K023788 | COLUMBUS (CR) TOTAL KNEE SYSTEM | Dec 13, 2002 | Substantially Equivalent | AESCULAP, INC. |
| K020703 | SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING | Nov 13, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K023416 | MODIFICATION TO VKS KNEE SYSTEM | Nov 08, 2002 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K022672 | COLUMBUS TOTAL KNEE SYSTEM (CR) | Nov 08, 2002 | Substantially Equivalent | AESCULAP, INC. |
| K022204 | VKS KNEE SYSTEM | Oct 18, 2002 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K021451 | DURACON CS TIBIAL INSERT | Oct 18, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K023211 | NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS | Oct 17, 2002 | Substantially Equivalent | ZIMMER, INC. |
| K023186 | OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY | Oct 17, 2002 | Substantially Equivalent | EXACTECH, INC. |
| K021740 | TOTAL KNEE CEMENTED, SEMI-CONSTRAINED | Sep 23, 2002 | Substantially Equivalent | DJ ORTHOPEDICS, LLC |
| K022010 | TOTAL KNEE FEMORAL COMPONENT | Aug 19, 2002 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K022586 | ANTERIOR STABILIZED TIBIAL BEARINGS | Aug 15, 2002 | Substantially Equivalent | BIOMET ORTHOPEDICS, INC. |
| K021657 | UKNEE TOTAL KNEE SYSTEM | Aug 12, 2002 | Substantially Equivalent | UNITED ORTHOPEDIC CORP. |
| K021578 | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE | Aug 09, 2002 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K021313 | SEARCH EVOLUTION TOTAL KNEE SYSTEM | Jul 22, 2002 | Substantially Equivalent | AESCULAP, INC. |
| K013906 | HLS NOETOS SYSTEM | Jul 17, 2002 | Substantially Equivalent | TORNIER |
| K020114 | 3D KNEE | Jul 12, 2002 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K021908 | PROVEN MODULAR POSTERIOR STABILIZED FEMORAL | Jul 09, 2002 | Substantially Equivalent | STELKAST COMPANY |
| K020830 | SCORPIO INSET PATELLAR COMPONENT | Jun 06, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K021559 | ASCENT ALL-POLY PS TIBIAL BEARINGS | Jun 05, 2002 | Substantially Equivalent | BIOMET, INC. |
| K020383 | ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED | May 06, 2002 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K012778 | VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS | Mar 15, 2002 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K020214 | MEDIAL ROTATION KNEE SYSTEM | Feb 26, 2002 | Substantially Equivalent | ENGINEERING CONSULTING SERVICES, INC. |
| K020295 | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 | Feb 12, 2002 | Substantially Equivalent | IMPLEX CORP. |
| K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 | Jan 30, 2002 | Substantially Equivalent | ENDOTEC, INC. |
| K013991 | PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS | Dec 27, 2001 | Substantially Equivalent | ZIMMER, INC. |
| K012776 | DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT | Nov 16, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K012172 | DURACON PS LIPPED TIBIAL INSERT | Oct 10, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS |
| K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 | Sep 26, 2001 | Substantially Equivalent | IMPLEX CORP. |
| K012348 | MAXIM RPG PS FEMORAL COMPONENT | Aug 15, 2001 | Substantially Equivalent | BIOMET, INC. |
| K012251 | OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES | Jul 31, 2001 | Substantially Equivalent | EXACTECH, INC. |
| K012095 | THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) | Jul 26, 2001 | Substantially Equivalent | IMPLEX CORP. |
| K011904 | NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) | Jul 19, 2001 | Substantially Equivalent | IMPLEX CORP. |
| K011976 | OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) | Jul 16, 2001 | Substantially Equivalent | EXACTECH, INC. |
| K011643 | SCORPIO CR SUPERFLEX TIBIAL INSERT | Jun 28, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K003182 | ORTHOGENESIS LPS SYSTEM | Jun 27, 2001 | Substantially Equivalent | DEPUY, INC. |
| K003026 | PFC SIGMA LUGGED TIBIAL TRAY | Jun 19, 2001 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K011288 | TC-PLUS POROUS TIBIAL COMPONENTS | May 24, 2001 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K011258 | TC-PLUS POROUS FEMORAL COMPONENTS | May 24, 2001 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K011219 | ASCENT KNEE SYSTEM | May 18, 2001 | Substantially Equivalent | BIOMET, INC. |
| K010101 | GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM | May 17, 2001 | Substantially Equivalent | KINAMED, INC. |
| K003910 | NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS | Mar 19, 2001 | Substantially Equivalent | ZIMMER, INC. |
| K010434 | OPTETRAK B-SERIES TOTAL KNEE SYSTEM | Mar 13, 2001 | Substantially Equivalent | EXACTECH, INC. |
| K001147 | ENHANCED POLYETHYLENE KNEE PROSTHESES | Feb 15, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K004013 | IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY | Jan 25, 2001 | Substantially Equivalent | IMPLEX CORP. |
| K010027 | MAXIM KNEE SYSTEM | Jan 12, 2001 | Substantially Equivalent | BIOMET, INC. |
| K002740 | TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS | Nov 30, 2000 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K003296 | BIOMET SCK KNEE SYSTEM | Nov 06, 2000 | Substantially Equivalent | BIOMET, INC. |
| K002335 | NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA | Oct 25, 2000 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K000666 | TC-PLUS SOLUTION KNEE | Oct 13, 2000 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K002772 | ASCENT XXL CLOSED BOX FEMORAL COMPONENT | Oct 04, 2000 | Substantially Equivalent | BIOMET, INC. |
| K002735 | ASCENT XXL OPEN BOX FEMORAL COMPONENT | Sep 19, 2000 | Substantially Equivalent | BIOMET, INC. |
| K002678 | ASCENT KNEE SYSTEM | Sep 19, 2000 | Substantially Equivalent | BIOMET, INC. |
| K002281 | STELKAST PROVEN KNEE SYSTEM | Aug 17, 2000 | Substantially Equivalent | STELKAST COMPANY |
| K001456 | CONSENSUS KNEE SYSTEM | Aug 07, 2000 | Substantially Equivalent | HAYES MEDICAL, INC. |
| K994214 | GEM KNEE SYSTEM | Jul 19, 2000 | Substantially Equivalent | KINAMED, INC. |
| K000978 | ANATOMIC TOTAL KNEE PROSTHESIS | Jun 22, 2000 | Substantially Equivalent | BIOMET, INC. |
| K001307 | CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ | May 23, 2000 | Substantially Equivalent | IMPLEX CORP. |
| K000590 | LATERAL PIVOT INSERT | May 11, 2000 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K001010 | ASCENT KNEE REVISION FEMORAL STEM | Apr 27, 2000 | Substantially Equivalent | BIOMET, INC. |
| K000113 | PROVEN KNEE SYSTEM | Apr 04, 2000 | Substantially Equivalent | STELKAST COMPANY |
| K994370 | ORTHO DEVELOPMENT BALANCED KNEE SYSTEM | Mar 24, 2000 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K000091 | DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT | Mar 10, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K994128 | SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM | Mar 06, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K000232 | ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS | Feb 25, 2000 | Substantially Equivalent | CORIN U.S.A. |
| K994076 | IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY | Feb 18, 2000 | Substantially Equivalent | IMPLEX CORP. |
| K993371 | SADDLE SHAPED PATELLA | Dec 20, 1999 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K991882 | NEXFLEX TOTAL KNEE SYSTEM | Dec 08, 1999 | Substantially Equivalent | NEXMED, INC. |
| K993692 | DURACON INSET PATELLA, 25MM | Dec 02, 1999 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K991052 | FS 1000 KNEE SYSTEM | Nov 10, 1999 | Substantially Equivalent | RENAISSANCE INSTRUMENTS, LLC. |
| K993159 | MAXIM KNEE SYSTEM | Oct 14, 1999 | Substantially Equivalent | BIOMET, INC. |
| K993111 | ASCENT KNEE SYSTEM | Oct 05, 1999 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K991753 | MAXIM REMOVABLE MOLDED POLY TIBIA | Aug 17, 1999 | Substantially Equivalent | BIOMET, INC. |
| K991581 | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO | Jul 30, 1999 | Substantially Equivalent | ZIMMER, INC. |
| K984054 | AGC V2 REVISION KNEE SYSTEM | Jul 30, 1999 | Substantially Equivalent | BIOMET, INC. |
| K992167 | PERFORMANCE KNEE SYSTEM | Jul 28, 1999 | Substantially Equivalent | BIOMET, INC. |
| K991143 | MAGNA-ROM 21 KNEE SYSTEEM | Jun 11, 1999 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K991106 | P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY | Jun 09, 1999 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K991428 | ASCENT KNEE SYSTEM | May 21, 1999 | Substantially Equivalent | BIOMET, INC. |
| K991461 | OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT | May 17, 1999 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K972774 | GAS PLASMA STERILIZATION | May 05, 1999 | Substantially Equivalent | ZIMMER, INC. |
| K983835 | IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA | Mar 15, 1999 | Substantially Equivalent | IMPLEX CORP. |
| K981996 | TITANIUM FEMORAL COMPONENT | Mar 10, 1999 | Substantially Equivalent | BIOMET, INC. |
| K984623 | MAXIM REMOVABLE MOLDED POLY TIBIA | Mar 05, 1999 | Substantially Equivalent | BIOMET, INC. |
| K990030 | ADVANCED REVISION PRODUCT LINE EXTENSION | Feb 03, 1999 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K984291 | CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT | Feb 01, 1999 | Substantially Equivalent | IMPLEX CORP. |
| K984158 | P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY | Jan 28, 1999 | Substantially Equivalent | DEPUY, INC. |
| K983733 | SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS | Dec 18, 1998 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K980637 | IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT | Dec 16, 1998 | Substantially Equivalent | IMPLEX CORP. |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K983153 | NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS | Dec 04, 1998 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K983004 | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI | Nov 25, 1998 | Substantially Equivalent | HAYES MEDICAL, INC. |
| K980999 | ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT | Nov 06, 1998 | Substantially Equivalent | INSTRUMENT MAKAR, INC. |
| K982903 | SULZER ORTHOPEDICS FLUTED STEMS | Oct 21, 1998 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K982585 | DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM | Oct 05, 1998 | Substantially Equivalent for Some Indications | DEPUY ORTHOPAEDICS, INC. |
| K982869 | ASCENT SYSTEM | Sep 22, 1998 | Substantially Equivalent | BIOMET, INC. |
| K982302 | IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS | Jul 31, 1998 | Substantially Equivalent for Some Indications | IMPLEX CORP. |
| K974843 | DURACON(R) SMALL STABILIZER TIBIAL INSERT | Jun 18, 1998 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K981560 | IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM | Jun 08, 1998 | Substantially Equivalent | IMPLEX CORP. |
| K980781 | IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS | May 22, 1998 | Substantially Equivalent | IMPLEX CORP. |
| K980713 | FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM | May 22, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K980545 | THE NUFFIELD TOTAL KNEE SYSTEM | Apr 29, 1998 | Substantially Equivalent | CORIN U.S.A. |
| K980276 | STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM | Apr 24, 1998 | Substantially Equivalent | STELKAST COMPANY |
| K974556 | OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM | Feb 27, 1998 | Substantially Equivalent | OSTEONICS CORP. |
| K974328 | ADVANCE TOTAL KNEE SYSTEM | Jan 30, 1998 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K972643 | DEPUY AMK 3 PEG PATELLA | Jan 21, 1998 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K972967 | OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT | Jan 16, 1998 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K973595 | THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM | Dec 19, 1997 | Substantially Equivalent | CORIN U.S.A. |
| K973672 | FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA | Dec 18, 1997 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K973524 | ADVANCE MODULAR TIBIAL COMPONENT | Dec 12, 1997 | Substantially Equivalent for Some Indications | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K973412 | NATURAL-KNEE II CONSTRAINED KNEE SYSTEM | Dec 08, 1997 | Substantially Equivalent for Some Indications | SULZER ORTHOPEDICS, INC. |
| K973406 | OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT | Dec 08, 1997 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K972270 | NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT | Nov 24, 1997 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K973164 | HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS | Nov 20, 1997 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K973121 | INTERAX TOTAL KNEE SYSTEM | Nov 18, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K972864 | DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS | Oct 29, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K972863 | DURATION STABILIZED UHMWPE KNEE COMPONENTS | Oct 29, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K972770 | ADVANCE ULTRA-CONGRUENT TIBIAL INSERT | Oct 21, 1997 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K972752 | DURACON CONVERSION METAL BACKED PATELLA | Oct 21, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K972501 | APOLLO REVISION/CONSTRAINED KNEE SYSTEM | Oct 01, 1997 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K972626 | ADVANCE KNEE SYSTEM | Sep 29, 1997 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K971770 | APOLLO KNEE FEMORAL SPACERS | Jul 31, 1997 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K971789 | IMPLEX CONTINUUM POROUS PATELLAR | Jul 24, 1997 | Substantially Equivalent for Some Indications | IMPLEX CORP. |
| K971189 | P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) | Jul 17, 1997 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K971652 | P.F.C. SIGMA INSET PATELLA | Jul 16, 1997 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K971550 | KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS | Jul 08, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K965173 | DURATION STABILIZED UHMWPE KNEE COMPONENTS | Jun 11, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K970758 | DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE | May 22, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | Apr 30, 1997 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K970031 | FOUNDATION KNEE SYSTEM TIBIAL COMPONENT | Apr 02, 1997 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K961021 | KIRSCHNER KNEE MODIFIED | Mar 17, 1997 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K964951 | KINEMAX PLUS TIBIAL SPACERS | Feb 24, 1997 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K963148 | NEXGEN COMPLETE KNEE SOLUTION | Feb 13, 1997 | Substantially Equivalent | ZIMMER, INC. |
| K963255 | PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT | Jan 02, 1997 | Substantially Equivalent for Some Indications | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| K964008 | FOUNDATION KNEE SYSTEM | Dec 27, 1996 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K963796 | KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS | Dec 09, 1996 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT | Dec 05, 1996 | Substantially Equivalent for Some Indications | SMITH & NEPHEW RICHARDS, INC. |
| K963709 | CEMENT-ON FEMORAL STEM | Dec 04, 1996 | Substantially Equivalent | BIOMET, INC. |
| K960856 | KONSTRUCT PATELLAR COMPONENT | Nov 27, 1996 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K963242 | DURACON POSTERIOR FEMORAL SPACER | Nov 14, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K963117 | P.F.C. CRUCIATE RETAING KNEE SYSTEM | Nov 06, 1996 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K963028 | TIBIAL INSERT | Oct 01, 1996 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K962196 | NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS | Aug 23, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K962152 | OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM | Aug 14, 1996 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K960976 | KINEMATIC II REPLACEMENT TIBIAL INSERTS | Aug 07, 1996 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K962137 | GENESIS II CONSTRAINED SYSTEM | Aug 02, 1996 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) | Jul 10, 1996 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K961483 | DURACON ALL POLYETHYLENE PATELLA II | Jul 09, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K961482 | DURACON INSET PATELLA WITH CENTRAL PEG | Jul 05, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K961379 | DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) | Jun 18, 1996 | Substantially Equivalent | DEPUY, INC. |
| K954818 | CONSENSUS POSTERIOR STABILIZED KNEE | May 22, 1996 | Substantially Equivalent for Some Indications | U.S. MEDICAL PRODUCTS, INC. |
| K934695 | NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA | May 02, 1996 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K960279 | NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES | Apr 26, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K953443 | CONSENSUS PCL SUBSITUTING TIBIAL INSERT | Apr 26, 1996 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K960535 | APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA | Apr 23, 1996 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K952943 | CONSENSUS ALL POLY TIBIA | Apr 01, 1996 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K951185 | NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE | Mar 15, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K955884 | COORDINATE REVISION KNEE SYSTEM | Mar 13, 1996 | Substantially Equivalent | DEPUY, INC. |
| K943025 | FREEMAN/SAMUELSON TOTAL KNEE SYSTEM | Mar 13, 1996 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K954208 | OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY | Feb 26, 1996 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K955421 | OSTEONICS N2/VAC PACKAGING PROCESS | Feb 21, 1996 | Substantially Equivalent | OSTEONICS CORP. |
| K953274 | GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM | Feb 05, 1996 | Substantially Equivalent for Some Indications | SMITH & NEPHEW RICHARDS, INC. |
| K954909 | PROFIX POSTERIOR-STABILIZED KNEE SYSTEM | Jan 31, 1996 | Substantially Equivalent for Some Indications | SMITH & NEPHEW RICHARDS, INC. |
| K953439 | ULTRACK TOTAL KNEE SYSTEM | Jan 30, 1996 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K954684 | DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT | Jan 26, 1996 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K952830 | DARWIN KNEE SYSTEM (TC3) | Jan 18, 1996 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K954138 | DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT | Nov 21, 1995 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K940861 | PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE | Sep 18, 1995 | Substantially Equivalent | HOWMEDICA CORP. |
| K952271 | GENESIS CONSTRAINED SYSTEM (GCS) | Sep 08, 1995 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K951987 | GENESIS II TOTAL KNEE SYSTEM | Aug 22, 1995 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K944321 | S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II | Aug 14, 1995 | Substantially Equivalent for Some Indications | JOINT MEDICAL PRODUCTS CORP. |
| K951956 | OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES | Aug 11, 1995 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K936008 | DURACON BASEPLATES | Aug 09, 1995 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K946088 | GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM | Aug 08, 1995 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K951027 | DEPUY AMK CO-CR FINNED TIBIAL TRAY | Jul 17, 1995 | Substantially Equivalent | DEPUY, INC. |
| K951655 | DURACON RECESSED PATELLA | Jul 11, 1995 | Substantially Equivalent | HOWMEDICA CORP. |
| K946150 | CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK) | Jul 11, 1995 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K935523 | NATURAL-KNEE(R)/APOLLO(TM) KNEE | Jun 06, 1995 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K945589 | CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE | May 31, 1995 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K936159 | NATURAL-KNEE II SYSTEM | May 22, 1995 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K935080 | INSALL-BURSTEIN II | May 22, 1995 | Substantially Equivalent for Some Indications | HOSPITAL FOR SPECIAL SURGERY |
| K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED | May 15, 1995 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K932070 | DURACON STABILIZER FEMORAL COMPONENT AND INSERT | Mar 22, 1995 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K945087 | ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE | Mar 17, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K933494 | EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM | Mar 10, 1995 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K932690 | EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY | Feb 09, 1995 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K941306 | FOUNDATION KNEE AUGMENTATION BLOCKS | Feb 08, 1995 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K934381 | APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT | Feb 08, 1995 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K935789 | POSTERIOR STABILIZED APOLLO KNEE SYSTEM | Feb 06, 1995 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K941769 | KNEE PROTHESIS | Feb 01, 1995 | Substantially Equivalent for Some Indications | JOINT MEDICAL PRODUCTS CORP. |
| K940813 | OSTEONICS(R) SERIES 7000 TOTAL KNEE | Jan 30, 1995 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K933785 | NEXT GENERATION KNEE SYSTEM | Jan 30, 1995 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K943299 | DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY | Jan 27, 1995 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K933229 | APOLLO KNEE FEMORAL COMPONENT | Jan 27, 1995 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K936274 | KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM | Jan 18, 1995 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K941755 | ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT | Jan 17, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K933610 | EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS | Jan 17, 1995 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K933958 | RICHARDS TOTAL KNEE SYSTEM | Jan 09, 1995 | Substantially Equivalent for Some Indications | SMITH & NEPHEW RICHARDS, INC. |
| K943462 | DARWIN KNEE SYSTEM | Dec 21, 1994 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K944285 | OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS | Dec 19, 1994 | Substantially Equivalent | OSTEONICS CORP. |
| K944845 | ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT | Dec 15, 1994 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K935773 | EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT | Dec 09, 1994 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K941128 | OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS | Dec 08, 1994 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K931466 | PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI | Dec 06, 1994 | Substantially Equivalent | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K940713 | PCA MODULAR PRIMARY/REVISION PATELLA | Nov 10, 1994 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K933539 | FOUNDATION POSTERIOR STABILIZED KNEE | Nov 08, 1994 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K935726 | EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT | Oct 20, 1994 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K932776 | CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS | Oct 20, 1994 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER | Oct 18, 1994 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K932677 | AXIOM TOTAL KNEE SYSTEM | Oct 14, 1994 | Substantially Equivalent | ORTHOMET, INC. |
| K931960 | NUFFIELD TOTAL KNEE | Oct 07, 1994 | Substantially Equivalent for Some Indications | TURNKEY INTERGRATION USA, INC. |
| K940235 | ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT | Oct 05, 1994 | Substantially Equivalent for Some Indications | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K936037 | S-ROM NOILES CRUCIATE RETAINING KNEE | Oct 03, 1994 | Substantially Equivalent for Some Indications | JOINT MEDICAL PRODUCTS CORP. |
| K932837 | CONSENSUS KNEE SYSTEM - PRIMARY KNEE | Sep 27, 1994 | Substantially Equivalent for Some Indications | U.S. MEDICAL PRODUCTS, INC. |
| K936079 | ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT | Sep 07, 1994 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K934166 | NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION | Sep 07, 1994 | Substantially Equivalent for Some Indications | CORIN ORTHOPEDIC PRODUCTS |
| K932210 | ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT | Sep 07, 1994 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K934620 | ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE | Sep 01, 1994 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K933290 | ORTHOLOC ADVANTIM | Sep 01, 1994 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K933289 | THICK TIBIAL INSERT | Aug 25, 1994 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K933843 | LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED | Aug 05, 1994 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K932425 | FOUNDATION MODULAR TIBIAL BASEPLATE | Jul 22, 1994 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K932246 | FOUNDATION METAL-BACKED PATELLA | Jul 22, 1994 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K931651 | NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW | Jul 18, 1994 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K934589 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED | Jul 13, 1994 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K932911 | ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT | Jun 30, 1994 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K933867 | UNIVERSAL INSET PATELLA | Jun 06, 1994 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA | Jun 03, 1994 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K934354 | LACEY ALL POLYETHYLENE TIBIAL COMPONENT | Jun 03, 1994 | Substantially Equivalent | DOW CORNING WRIGHT |
| K926228 | DURACON CRUCIFORM TIBIAL BASEPLATE | Feb 22, 1994 | Substantially Equivalent | HOWMEDICA CORP. |
| K924482 | HOWMEDICAL TOTAL KNEE STEM EXTENDER | Feb 22, 1994 | Substantially Equivalent | HOWMEDICA CORP. |
| K932858 | ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT | Feb 16, 1994 | Substantially Equivalent | DOW CORNING WRIGHT |
| K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS | Jan 25, 1994 | Substantially Equivalent | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K924340 | P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT | Jan 25, 1994 | Substantially Equivalent | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K925072 | AMK LANDMARK REVISION KNEE SYSTEM | Jan 21, 1994 | Substantially Equivalent | DEPUY, INC. |
| K925837 | AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY | Jan 07, 1994 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K930228 | ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE | Nov 30, 1993 | Substantially Equivalent | DOW CORNING WRIGHT |
| K930831 | MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS | Nov 16, 1993 | Substantially Equivalent | ZIMMER, INC. |
| K924698 | AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY | Oct 27, 1993 | Substantially Equivalent | ORTHOMET, INC. |
| K930595 | AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY | Oct 22, 1993 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K922859 | ANATOMICAL TYPE KNEE SYSTEM | Sep 23, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K930554 | THE NATURAL-KNEE REVISION | Sep 21, 1993 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K922841 | BIOPRO MODULAR TIBIAL TRAY | Sep 21, 1993 | Substantially Equivalent | BIOPRO, INC. |
| K933304 | ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED | Aug 30, 1993 | Substantially Equivalent | DEPUY, INC. |
| K925900 | LACEY REVISION FEMORAL COMPONENT | Aug 24, 1993 | Substantially Equivalent | DOW CORNING WRIGHT |
| K930189 | ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP | Aug 06, 1993 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | Aug 03, 1993 | Substantially Equivalent | DOW CORNING WRIGHT |
| K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP | Aug 02, 1993 | Substantially Equivalent | DOW CORNING WRIGHT |
| K921182 | ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT | Jul 23, 1993 | Substantially Equivalent | BIOMET, INC. |
| K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM | Jul 13, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K925242 | APOLLO(TM) KNEE SYSTEM | Jun 04, 1993 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K926257 | ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT | May 18, 1993 | Substantially Equivalent | DOW CORNING WRIGHT |
| K915525 | WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP | May 05, 1993 | Substantially Equivalent | DOW CORNING WRIGHT |
| K923443 | NATURAL-KNEE ALL-POLY TIBIA | Mar 31, 1993 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K925901 | KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER | Mar 22, 1993 | Substantially Equivalent | HOWMEDICA CORP. |
| K923573 | DURACON METAL BACKED PATELLA | Mar 16, 1993 | Substantially Equivalent | HOWMEDICA CORP. |
| K924940 | FEMORAL & TIBIAL AUGMENT BLOCK | Mar 09, 1993 | Substantially Equivalent for Some Indications | JOINT MEDICAL PRODUCTS CORP. |
| K915798 | PSK POSTERIOR STABILIZED TOATAL KNEE | Mar 04, 1993 | Substantially Equivalent | IMPLANTOLOGY CORP. |
| K925372 | OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP | Feb 12, 1993 | Substantially Equivalent | OSTEONICS CORP. |
| K915584 | CRK CONDYLAR RESURFACING TOTAL KNEE | Feb 12, 1993 | Substantially Equivalent | IMPLANTOLOGY CORP. |
| K923277 | FOUNDATION KNEE SYSTEM | Feb 09, 1993 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS | Nov 09, 1992 | Substantially Equivalent | JOHNSON & JOHNSON INTERNATIONAL |
| K923451 | AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY | Oct 20, 1992 | Substantially Equivalent | DEPUY, INC. |
| K922734 | AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM | Sep 10, 1992 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K922048 | DURACON ALL PLASTIC TIBIAL COMPONENT | Sep 08, 1992 | Substantially Equivalent | HOWMEDICA CORP. |
| K921640 | KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT | Sep 08, 1992 | Substantially Equivalent | HOWMEDICA CORP. |
| K922620 | AMK FIXED STEM CEMENTED TIBIAL TRAY | Sep 03, 1992 | Substantially Equivalent | DEPUY, INC. |
| K920080 | CONTINUUM KNEE SYSTEM | Sep 01, 1992 | Substantially Equivalent for Some Indications | TECHMEDICA, INC. |
| K915512 | DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS | Aug 18, 1992 | Substantially Equivalent for Some Indications | PFIZER HOSPITAL PRODUCTS GROUP, INC. |
| K922285 | AGC AND MAXIM KNEE COMPONENTS WITH NTS | Aug 13, 1992 | Substantially Equivalent | BIOMET, INC. |
| K922104 | 7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA | Aug 11, 1992 | Substantially Equivalent | OSTEONICS CORP. |
| K910992 | AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE | Aug 10, 1992 | Substantially Equivalent | DEPUY, INC. |
| K920396 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM | Aug 07, 1992 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K920698 | FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS | Aug 03, 1992 | Substantially Equivalent | ORTHOMET, INC. |
| K920426 | PSK FEMORAL AND TIBIAL INSERT COMPONENT | Aug 03, 1992 | Substantially Equivalent | ORTHOMET, INC. |
| K920524 | OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION | May 15, 1992 | Substantially Equivalent | OSTEONICS CORP. |
| K914565 | OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM | May 15, 1992 | Substantially Equivalent | OSTEONICS CORP. |
| K920034 | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC | Mar 18, 1992 | Substantially Equivalent | PFIZER HOSPITAL PRODUCTS GROUP, INC. |
| K914072 | CONTINUUM KNEE SYSTEM (CKS) | Feb 18, 1992 | Substantially Equivalent | TECHMEDICA, INC. |
| K915192 | 7000 SERIES MODULAR TIBIAL COMPONENTS | Feb 14, 1992 | Substantially Equivalent | OSTEONICS CORP. |
| K915186 | 7000 SERIES TOTAL KNEE PATELLAR COMPONENTS | Feb 14, 1992 | Substantially Equivalent | OSTEONICS CORP. |
| K915132 | MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM | Feb 11, 1992 | Substantially Equivalent | BIOMET, INC. |
| K914169 | WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP | Jan 27, 1992 | Substantially Equivalent | DOW CORNING WRIGHT |
| K913492 | KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM | Dec 27, 1991 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K914230 | AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY | Dec 16, 1991 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K911972 | FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT | Oct 25, 1991 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K912894 | AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT | Oct 18, 1991 | Substantially Equivalent | ORTHOMET, INC. |
| K913188 | KINEMAX PLUS TIBIAL INSERT | Oct 11, 1991 | Substantially Equivalent | HOWMEDICA CORP. |
| K912663 | NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT | Sep 16, 1991 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K910940 | ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY | Sep 10, 1991 | Substantially Equivalent | DEPUY, INC. |
| K912266 | MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP | Aug 20, 1991 | Substantially Equivalent for Some Indications | OROTHMET, INC. |
| K912245 | AGC REVISION KNEE PROTHESIS | Aug 19, 1991 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K912147 | OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP | Aug 13, 1991 | Substantially Equivalent | OSTEONICS CORP. |
| K904448 | TOWNLEY TOTAL KNEE (TTK) | Jul 17, 1991 | Substantially Equivalent | BIOPRO, INC. |
| K911572 | MG II POROUS COBAL T-CHROME FEMORAL COMPONENT | Jul 01, 1991 | Substantially Equivalent | ZIMMER, INC. |
| K905613 | MTS KNEE SYSTEM | Jun 24, 1991 | Substantially Equivalent for Some Indications | T & R MFG., INC. |
| K910235 | PCA MTK II TOTAL KNEE SYSTEM | Jun 21, 1991 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K910990 | OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS | Jun 19, 1991 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K905810 | NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION | Jun 12, 1991 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K910989 | OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP | Jun 05, 1991 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K911198 | TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY | May 23, 1991 | Substantially Equivalent | ORTHOMET, INC. |
| K911197 | PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM | May 23, 1991 | Substantially Equivalent | ORTHOMET, INC. |
| K910563 | P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL | May 23, 1991 | Substantially Equivalent | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K910500 | HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM | May 06, 1991 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K904208 | KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM | Apr 01, 1991 | Substantially Equivalent | HOWMEDICA CORP. |
| K905076 | WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT | Feb 13, 1991 | Substantially Equivalent | DOW CORNING WRIGHT |
| K904205 | AMK MODULAR TIBIAL WEDGE SYSTEM | Oct 22, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K904300 | INSET PATELLAR COMPONENT | Oct 17, 1990 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K904170 | PCA (R) TIBIAL BONE WEDGES | Oct 17, 1990 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K901085 | DORR KNEE SYSTEM | Sep 19, 1990 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K902335 | NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM) | Aug 22, 1990 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K902246 | AMK UNIVERSAL FEMORAL COMPONENT | Aug 09, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K901406 | ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED | Jul 23, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K895145 | SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR | Jul 06, 1990 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K901936 | PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP | Jul 03, 1990 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K901992 | WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM | Jun 26, 1990 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K901457 | CONTINUUM KNEE SYSTEM (CKS) | Jun 20, 1990 | Substantially Equivalent for Some Indications | TECHMEDICA, INC. |
| K901338 | KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM | May 22, 1990 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K892503 | NUFFIELD TOTAL KNEE | May 04, 1990 | Substantially Equivalent for Some Indications | ORTHOPEDIC SYSTEMS, INC. |
| K896081 | WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA | Mar 02, 1990 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K896397 | S-ROM(TM)/NOILES(TM) MARK 5 KNEE | Feb 22, 1990 | Substantially Equivalent for Some Indications | JOINT MEDICAL PRODUCTS CORP. |
| K896542 | ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM)) | Feb 15, 1990 | Substantially Equivalent | TECHMEDICA, INC. |
| K895639 | MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR | Feb 08, 1990 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K894403 | PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT | Feb 02, 1990 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K894937 | SHAW KNEE MODULAR TIBIAL TRAY-POROUS | Jan 31, 1990 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K895962 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS | Jan 09, 1990 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K896045 | WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM | Jan 05, 1990 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K896452 | KINEMAX TIBIAL STEM EXTENSION | Jan 04, 1990 | Substantially Equivalent | HOWMEDICA CORP. |
| K893040 | ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG | Nov 20, 1989 | Substantially Equivalent | ORTHOMET, INC. |
| K894658 | KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS | Oct 20, 1989 | Substantially Equivalent | HOWMEDICA CORP. |
| K894504 | WHITESIDE ORTHOLOC M.A. TIBIAL BASE | Oct 17, 1989 | Substantially Equivalent | DOW CORNING WRIGHT |
| K894334 | SECOND GENERATION KNEE SYSTEM | Oct 06, 1989 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K893762 | PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT | Sep 15, 1989 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K892800 | MG II POROUS TOTAL KNEE SYSTEM | Aug 03, 1989 | Substantially Equivalent | ZIMMER, INC. |
| K893252 | WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM | Jul 28, 1989 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K892394 | P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS | Jul 19, 1989 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K892366 | POROUS GENESIS STEMMED TIBIAL COMPONENT | Jul 19, 1989 | Substantially Equivalent for Some Indications | RICHARDS MEDICAL CO., INC. |
| K890132 | POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. | Jul 19, 1989 | Substantially Equivalent for Some Indications | RICHARDS MEDICAL CO., INC. |
| K885036 | POROUS COATED GENESIS FEMORAL COMPONENT | Apr 19, 1989 | Substantially Equivalent for Some Indications | RICHARDS MEDICAL CO., INC. |
| K884796 | P.F.C.(TM) MODULAR KNEE SYSTEM | Mar 29, 1989 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K882322 | CONTINUUM KNEE SYSTEM (CKS) | Feb 08, 1989 | Substantially Equivalent for Some Indications | BUCKMAN CO., INC. |
| K884338 | LACEY POSTERIOR STABILIZED KNEE SYSTEM | Feb 01, 1989 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K884410 | OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM | Jan 18, 1989 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K884398 | OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS | Jan 17, 1989 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K883122 | AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT | Dec 01, 1988 | Substantially Equivalent | DEPUY, INC. |
| K883215 | KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S | Nov 09, 1988 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K882234 | JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS | Oct 20, 1988 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K874923 | PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE | Oct 12, 1988 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K881982 | PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP | Jul 19, 1988 | Substantially Equivalent | HOWMEDICA CORP. |
| K874635 | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES | Mar 10, 1988 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K875201 | PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG | Feb 17, 1988 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K873602 | INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM | Jan 27, 1988 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K874547 | KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED | Dec 18, 1987 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K872379 | INSALL/BURSTEIN* II MODULAR TOTAL KNEE | Oct 28, 1987 | Substantially Equivalent | ZIMMER, INC. |
| K873197 | AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT | Oct 23, 1987 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K872134 | PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON | Oct 14, 1987 | Substantially Equivalent | ORTHOMET, INC. |
| K871349 | HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT | Sep 01, 1987 | Substantially Equivalent | HOWMEDICA CORP. |
| K872266 | CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE | Aug 14, 1987 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K871776 | WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY | Aug 03, 1987 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K871146 | GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) | Jul 31, 1987 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K871585 | MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM | Jul 21, 1987 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K870273 | LACEY METAL BACKED PATELLA PROSTHESIS | Jul 01, 1987 | Substantially Equivalent | DOW CORNING WRIGHT |
| K871772 | KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY | Jun 03, 1987 | Substantially Equivalent | HOWMEDICA CORP. |
| K871769 | OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION) | Jun 02, 1987 | Substantially Equivalent | OSTEONICS CORP. |
| K870730 | NOILES TOTAL KNEE PROSTHESIS | May 26, 1987 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K870702 | ADG PATELLAR COMPONENT | Apr 17, 1987 | Substantially Equivalent | BUCKMAN CO., INC. |
| K864632 | P.C.A. MODULAR KNEE SYSTEM | Mar 06, 1987 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K864518 | LACEY PRESS-FIT CONDYLAR TOTAL KNEE | Mar 04, 1987 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K864671 | ANATOMIC MODULAR KNEE (AMK) SYSTEM | Feb 06, 1987 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K864627 | WHITESIDE ORTHOLOC II METAL BACKED PATELLA | Feb 04, 1987 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K863668 | OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM | Dec 19, 1986 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K863667 | MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS | Dec 12, 1986 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K863805 | MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME | Dec 02, 1986 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K861266 | HOWMEDICA KINEMATIC PLUS KNEE SYSTEM | Jul 24, 1986 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K860654 | M.C.R. KNEE PROSTHESIS (SERIES 3000) | Mar 14, 1986 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K860594 | SYNATOMIC REVISION FEMORAL PROSTHESIS | Mar 14, 1986 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K855166 | THACKRAY TOTAL CONDYLAR KNEES | Mar 13, 1986 | Substantially Equivalent | THACKRAY USA |
| K853991 | HOFMANN KNEE | Feb 21, 1986 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K854883 | OMKNEE SYSTEM | Feb 18, 1986 | Substantially Equivalent | ORTHOMET, INC. |
| K853661 | MILLAR/GALANTE PRECOATED TOTAL KNEE | Dec 09, 1985 | Substantially Equivalent | ZIMMER, INC. |
| K852059 | THE P.C.A. DOME PATELLA COMPONENT | Jul 16, 1985 | Substantially Equivalent | HOWMEDICA CORP. |
| K851231 | RMC POSTERIOR STABILIZED KNEE SYSTEM | May 22, 1985 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K843907 | POROUS COATED TITANIUM KNEE PROSTHES- | Jan 10, 1985 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K843242 | TRICON M TIBIAL COMPONENT | Sep 26, 1984 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K843241 | TRICON-P TIBIAL COMPONENT | Sep 26, 1984 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K834432 | ANTHRO-MODULAR TOTAL KNEE | Apr 11, 1984 | Substantially Equivalent | ZIMMER, INC. |
| K833363 | CLOUTIER II FIBER METAL TOTAL KNEE | Feb 13, 1984 | Substantially Equivalent | ZIMMER, INC. |
| K840100 | PATELLA PROSTHESIS | Feb 09, 1984 | Substantially Equivalent | TECHMEDICA, INC. |
| K833921 | AGC TOTAL KNEE PROSTHESIS | Jan 31, 1984 | Substantially Equivalent | BIOMET, INC. |
| K833411 | KNEE PROSTHESIS-PATELLA COMPONENT | Dec 22, 1983 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K830927 | KNEE PROSTHESIS-TIBIAL COMPONENT | Jul 19, 1983 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K830121 | INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE | Apr 26, 1983 | Substantially Equivalent | ZIMMER, INC. |
| K813598 | 101 TOTAL CONDYLAR KNEE SYSTEM | Feb 10, 1982 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K810328 | BIO CONDYLAR TM KNEE | Apr 08, 1981 | Substantially Equivalent | DEPUY, INC. |
| K810326 | POROCOAT TM TOWNLEY ANATOMIC KNEE | Mar 11, 1981 | Substantially Equivalent | DEPUY, INC. |
| K802922 | POROUS COATED ANATOMICAL-TOTAL KNEE | Dec 17, 1980 | Substantially Equivalent | HOWMEDICA CORP. |
| K792089 | THE HOWMEDICA KINEMATIC KNEE SYSTEM | May 06, 1980 | Substantially Equivalent | HOWMEDICA CORP. |
| K790219 | PROTHESIS, RETAINED GEOMETRIC KNEE | May 08, 1979 | Substantially Equivalent | ZIMMER, INC. |
| K781294 | PROSTHESIS, KNEE, TOTAL | Aug 14, 1978 | Substantially Equivalent | BIOMET, INC. |
| K772225 | PATELLAR PROSTHESIS | Dec 08, 1977 | Substantially Equivalent | CUTTER LABORATORIES, INC. |
| K771598 | PATELLA PROSTHESIS/TRAIL COMPONENT | Aug 26, 1977 | Substantially Equivalent | DEPUY, INC. |
| K760200 | PROSTHESIS, PATELLAR ARTICULAR SURFACE | Jul 20, 1976 | Substantially Equivalent | DEPUY, INC. |
FEI Numbers
This FDA classification entry is associated with 320 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 320 registration numbers. Click on an entry to view related FDA registrations.