Product Code: JDI
FDA class 2
21 CFR 888.3350
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Orthopedic
A semi-constrained metal and polymer cemented hip prosthesis is a total hip replacement implant that uses a cemented fixation technique to anchor metal femoral and polymer acetabular components, providing controlled constraint to the articulation and used in patients with end-stage hip arthritis or other joint destructive conditions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDI, regulated under 21 CFR 888.3350, within the Orthopedic medical specialty. This device is an implant.
510(k)s
561
FEI Numbers
231
Registration Numbers
231
Unique Applicants
123
Years Active
47
Basic Information
- Product Code
- JDI
- Device Class
- FDA class 2
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 561 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Oct 21, 2024 | Substantially Equivalent | Smith & Nephew, Inc. |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Aug 02, 2024 | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Apr 12, 2024 | Substantially Equivalent | Howmedica Osteonics Corp. dba Stryker Orthopaedics |
| K233261 | Global Modular Replacement System | Dec 08, 2023 | Substantially Equivalent | Howmedica Osteonics Corp aka Stryker Orthopaedics |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Jan 26, 2023 | Substantially Equivalent | Howmedica Osteonics Corp., dba Stryker Orthopaedics |
| K220216 | C-Stem AMT LE Prosthesis | Jul 22, 2022 | Substantially Equivalent | DePuy Ireland UC |
| K213701 | Exeter® X3® RimFit® Cup | Feb 01, 2022 | Substantially Equivalent | Howmedica Osteonics Corp., dba Stryker Orthopaedics |
| K213816 | MPO Hip Instruments | Jan 05, 2022 | Substantially Equivalent | MicroPort Orthopedics Inc. |
| K210842 | VerSys Cemented Revision/Calcar | Dec 10, 2021 | Substantially Equivalent | Zimmer, Inc. |
| K203815 | ELEOS Limb Salvage System with BioGrip | Jun 09, 2021 | Substantially Equivalent | Onkos Surgical |
| K203588 | ELEOS Limb Salvage System | Feb 05, 2021 | Substantially Equivalent | Onkos Surgical |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Dec 11, 2020 | Substantially Equivalent | Onkos Surgical |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Dec 10, 2020 | Substantially Equivalent | MicroPort Orthopedics Inc. |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Aug 13, 2020 | Substantially Equivalent | Howmedica Osteonics Corp |
| K191449 | ZCA All-Poly Acetabular Cups | Jul 16, 2020 | Substantially Equivalent | Zimmer, Inc. |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Jul 09, 2020 | Substantially Equivalent | Zimmer, Inc. |
| K191735 | CPT Hip System | Mar 20, 2020 | Substantially Equivalent | Zimmer Inc |
| K191056 | Conformity stem, cemented | Jan 03, 2020 | Substantially Equivalent | United Orthopedic Corporation |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Aug 28, 2019 | Substantially Equivalent | Stryker Orthopaedics |
| K181340 | Cemented TSI Hip Stem | Feb 11, 2019 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K180973 | Libertas Hip Replacement System | Sep 28, 2018 | Substantially Equivalent | Maxx Orthopedics, Inc |
| K162125 | MALUC Total Hip Arthroplasty System | May 10, 2017 | Substantially Equivalent | SurgTech, Inc., |
| K160923 | REDAPT Anteverted Cemented Liner | Nov 17, 2016 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K153057 | FitRite Total Hip Arthroplasty System | Jun 23, 2016 | Substantially Equivalent | EXCERA ORTHOPEDICS, INC. |
| K153725 | Corin TaperFit Hip Stem | Mar 25, 2016 | Substantially Equivalent | CORIN USA LIMITED |
| K153216 | Alpine Cemented Hip System | Feb 18, 2016 | Substantially Equivalent | ORTHO DEVELOPMENT CORPORATION |
| K152621 | OSS/Arcos IM Total Femur Rod | Oct 14, 2015 | Substantially Equivalent | BIOMET, INC. |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Jun 25, 2015 | Substantially Equivalent | BIOMET MANUFACTURING LLC |
| K142761 | Corin TaperFit Hip Stem | Apr 03, 2015 | Substantially Equivalent | CORIN USA |
| K141331 | BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) | Oct 27, 2014 | Substantially Equivalent | BIOMET, INC. |
| K142295 | Sirius Femoral Stem, Size 30A | Sep 15, 2014 | Substantially Equivalent | Biomet, Inc. |
| K141370 | RENOVIS CEMENTED HIP SYSTEM | Sep 02, 2014 | Substantially Equivalent | Renovis Surgical Technologies, Inc. |
| K130610 | SIRIUS FEMORAL STEM | Aug 30, 2013 | Substantially Equivalent | BIOMET, INC. |
| K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | Jun 28, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K123501 | OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS | Feb 27, 2013 | Substantially Equivalent | BIOMET, INC. |
| K121056 | METS MODULAR PROXIMAL FEMUR | Sep 20, 2012 | Substantially Equivalent | STANMORE IMPLANTS WORLDWIDE LTD. |
| K121055 | METS MODULAR TOTAL FEMUR | Sep 19, 2012 | Substantially Equivalent | STANMORE IMPLANTS WORLDWIDE LTD. |
| K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES | Jun 15, 2012 | Substantially Equivalent | MATERIALISE N.V. |
| K120578 | ACCOLADE II HIP STEM | Mar 29, 2012 | Substantially Equivalent | HOWMEDICA OSTEONICS |
| K111848 | EXETER X3 RIMFIT ACETABULAR CUP | Oct 05, 2011 | Substantially Equivalent | STRYKER CORP. |
| K110290 | EXETER HIP STEM | Sep 27, 2011 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | Dec 17, 2009 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | Jun 12, 2009 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K090208 | BIOPRO FEMORAL HEADS | May 22, 2009 | Substantially Equivalent | BIOPRO, INC. |
| K082792 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS | Dec 29, 2008 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K082239 | DEPUY C-STEM AMT | Aug 29, 2008 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K080539 | ACCIN UNIPOLAR HEAD SYSTEM | Jun 02, 2008 | Substantially Equivalent | ACCELERATED INNOVATION, LLC |
| K080885 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION | Apr 28, 2008 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K072857 | TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT | Feb 04, 2008 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K070399 | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES | May 04, 2007 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K070364 | 100KGY E-POLY MAXROM ACETABULAR LINERS | May 03, 2007 | Substantially Equivalent | BIOMET, INC. |
| K063278 | PORTLAND COBALT CHROME FEMORAL HEAD | Jan 12, 2007 | Substantially Equivalent | PORTLAND ORTHOPAEDICS LIMITED |
| K061344 | EXCIA TOTAL HIP SYSTEM LATERAL OFFSET | Aug 02, 2006 | Substantially Equivalent | AESCULAP, INC. |
| K052639 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER | May 03, 2006 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K052748 | SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS | Dec 02, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K052792 | ANTHOLOGY HIP STEM | Oct 07, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K051569 | RINGLOC BI-POLAR ACETABULAR COMPONENT | Sep 29, 2005 | Substantially Equivalent | BIOMET, INC. |
| K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS | Sep 23, 2005 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K051407 | LEGEND ALL-POLY CUP | Sep 08, 2005 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K051516 | TRABECULAR METAL REVISION SHELL LINERS | Jul 27, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K050441 | TAPER 2 POROUS FEMORAL STEM | Jun 29, 2005 | Substantially Equivalent | BIOMET, INC. |
| K051363 | RESTORATION MODULAR SYSTEM | Jun 23, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K051335 | ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS | Jun 21, 2005 | Substantially Equivalent | EXACTECH, INC. |
| K050105 | NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS | May 17, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K050138 | MODIFICATION TO: RESTORATION MODULAR SYSTEM | Mar 21, 2005 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K042959 | DEPUY C-STEM AMT HIP PROSTHESIS | Dec 22, 2004 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K033871 | IM TOTAL FEMUR | Apr 16, 2004 | Substantially Equivalent | BIOMET, INC. |
| K032730 | FIXION HIP SYSTEM | Mar 26, 2004 | Substantially Equivalent | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
| K034028 | ATH FEMORAL STEM | Mar 11, 2004 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K031474 | SC TOTAL HIP SYSTEM | Oct 15, 2003 | Substantially Equivalent | ORTHOPEDIC ALLIANCE LLC |
| K030867 | ESKA MODULAR HIP SYSTEM CEMENTED | Sep 22, 2003 | Substantially Equivalent | ESKA IMPLANTS GMBH |
| K031730 | 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS | Aug 29, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K032396 | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS | Aug 21, 2003 | Substantially Equivalent | BIOMET, INC. |
| K031744 | OMNIFIT HFX HIP STEM SERIES | Aug 08, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K030766 | OXINIUM FEMORAL HEADS | Jul 25, 2003 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K031734 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS | Jul 01, 2003 | Substantially Equivalent | BIOMET, INC. |
| K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM | Jun 06, 2003 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K030153 | ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 | Apr 01, 2003 | Substantially Equivalent | ZIMMER, INC. |
| K030265 | CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 | Mar 04, 2003 | Substantially Equivalent | ZIMMER, INC. |
| K024340 | SMITH & NEPHEW FEMORAL HEADS | Feb 26, 2003 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K022799 | TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE | Nov 21, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K023646 | EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM | Nov 13, 2002 | Substantially Equivalent | EXACTECH, INC. |
| K023453 | DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS | Nov 13, 2002 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K023085 | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM | Oct 17, 2002 | Substantially Equivalent | BIOMET ORTHOPEDICS, INC. |
| K022958 | TOTAL HIP FEMORAL HEADS AND LINERS | Oct 02, 2002 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K022094 | PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING | Jul 25, 2002 | Substantially Equivalent | BIOMET, INC. |
| K022077 | 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) | Jul 25, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K021822 | R120 MODULAR TOTAL HIP SYSTEM | Jul 23, 2002 | Substantially Equivalent | OSTEOIMPLANT TECHNOLOGY, INC. |
| K021380 | OSS LES PROXIMAL FEMORAL COMPONENT | May 28, 2002 | Substantially Equivalent | BIOMET, INC. |
| K021310 | 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) | May 21, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K021178 | SL-PLUS LATERALIZED STEM | May 14, 2002 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K020989 | SUPER EON PLUS FEMORAL STEMS | Apr 26, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K020970 | MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) | Apr 04, 2002 | Substantially Equivalent | BIOMET, INC. |
| K020291 | EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER | Feb 27, 2002 | Substantially Equivalent | EXACTECH, INC. |
| K020076 | PATRIOT PROTRUSIO CAGE | Jan 30, 2002 | Substantially Equivalent | BIOMET ORTHOPEDICS, INC. |
| K011887 | AVALON CUP SYSTEM | Dec 27, 2001 | Substantially Equivalent | ORTHOPEDIC SOURCE INC. |
| K013352 | SUMMIT CEMENTED HIP PROSTHESIS | Dec 17, 2001 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K013350 | MODIFICATION TO DEPUY C-STEM SYSTEM | Nov 07, 2001 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | Oct 18, 2001 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K011774 | R120 MODULAR TOTAL HIP SYSTEM | Sep 05, 2001 | Substantially Equivalent | OSTEOIMPLANT TECHNOLOGY, INC. |
| K012493 | ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 | Aug 29, 2001 | Substantially Equivalent | EXACTECH, INC. |
| K011715 | MACROPORE IB RESORBABLE PLUG | Aug 27, 2001 | Unknown | MACROPORE BIOSURGERY, INC. |
| K012019 | COLOR BUFFED (CB) DDH FEMORAL STEM | Jul 20, 2001 | Substantially Equivalent | BIOMET, INC. |
| K012026 | TRIDENT ALL POLY CUP | Jul 18, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K011455 | BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER | Jul 18, 2001 | Substantially Equivalent | BIOMET, INC. |
| K011623 | EXETER HIP SYSTEM WITH V40 TAPER | Jun 15, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K011367 | EXCEL FRACTURE CEMENTED HIP STEM | Jun 15, 2001 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K011218 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 | May 16, 2001 | Substantially Equivalent | EXACTECH, INC. |
| K010529 | TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA | Apr 27, 2001 | Unknown | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K010757 | LFIT V40 FEMORAL HEAD COMPONENTS | Apr 11, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K010310 | MODIFICATION TO TRIDENT ALL POLY CUP | Mar 20, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K003976 | BAUMER MULLER HIP PROSTHESIS | Mar 19, 2001 | Substantially Equivalent | BAUMER S.A. |
| K003975 | BAUMER CEMENTED HIP PROSTHESIS | Mar 19, 2001 | Substantially Equivalent | BAUMER S.A. |
| K003666 | TAPER-FIT TOTAL HIP SYSTEM | Feb 08, 2001 | Substantially Equivalent | CORIN U.S.A. |
| K001956 | TRIDENT ALL POLY CUP | Dec 11, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K003421 | DEPUY C-STEM SYSTEM | Dec 01, 2000 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K002757 | ONCOLOGY SALVAGE SYSTEM | Nov 24, 2000 | Substantially Equivalent | BIOMET, INC. |
| K002324 | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA | Aug 24, 2000 | Substantially Equivalent | SULZER MEDICA |
| K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | Aug 24, 2000 | Substantially Equivalent | IMPLEX CORP. |
| K001571 | BAUMER FEMORAL HEAD | Aug 04, 2000 | Substantially Equivalent | BAUMER S.A. |
| K002106 | NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER | Jul 27, 2000 | Substantially Equivalent | BIOMET, INC. |
| K001932 | TORNIER CEMENT RESTRICTOR | Jul 20, 2000 | Substantially Equivalent | TORNIER |
| K001376 | TI-MAX PROTRUSIO CAGE | Jul 20, 2000 | Substantially Equivalent | BIOMET, INC. |
| K001078 | SULZER ORTHOPEDICS MS-30 FEMORAL STEM | Jun 23, 2000 | Substantially Equivalent | SULZER ORTHOPEDICS, INC. |
| K001733 | ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES | Jun 20, 2000 | Substantially Equivalent | ZIMMER, INC. |
| K000817 | OMEGA II MODULAR TOTAL HIP SYSTEM | Jun 08, 2000 | Substantially Equivalent | OSTEOIMPLANT TECHNOLOGY, INC. |
| K001335 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED | May 18, 2000 | Substantially Equivalent | EXACTECH, INC. |
| K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | Mar 01, 2000 | Substantially Equivalent | IMPLEX CORP. |
| K000254 | PAR 5 ACETABULAR COMPONENT | Feb 07, 2000 | Substantially Equivalent | BIOMET, INC. |
| K994007 | MALLORY/HEAD SMOOTH FEMORAL COMPONENT | Feb 04, 2000 | Substantially Equivalent | BIOMET, INC. |
| K993713 | RIM-FIX, ACETABULAR CUP | Jan 28, 2000 | Substantially Equivalent | SURGICAL IMPLANTS INC. |
| K992409 | THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ | Oct 08, 1999 | Substantially Equivalent | IMPLEX CORP. |
| K992153 | PE-PLUS ACETABULAR CUP | Sep 23, 1999 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K992903 | COLOR BUFFED CEMENTED FEMORAL | Sep 17, 1999 | Substantially Equivalent | BIOMET, INC. |
| K992490 | B2C HIP SYSTEM | Aug 19, 1999 | Substantially Equivalent | LEPINE GROUPE SPA. |
| K991869 | COBREX HIP STEM, MODEL 01-128-XXXXX | Jul 14, 1999 | Substantially Equivalent | IMPLEX CORP. |
| K991622 | 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER | Jul 14, 1999 | Substantially Equivalent | STELKAST COMPANY |
| K992058 | BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM | Jul 01, 1999 | Substantially Equivalent | BIOMET, INC. |
| K991987 | COLOR BUFFED ANSWER CEMENTED FEMORAL | Jun 28, 1999 | Substantially Equivalent | BIOMET, INC. |
| K991538 | OPERA CUPFLANGED ACETABULAR COMPONENTS | Jun 03, 1999 | Substantially Equivalent | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| K991227 | 8MM FORGED CEMENTED STEM | Jun 01, 1999 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K990821 | PROVIDENCE CUP SYSTEM | Apr 29, 1999 | Substantially Equivalent | BIOPRO, INC. |
| K984227 | OMEGA II MODULAR TOTAL HIP SYSTEM | Apr 08, 1999 | Substantially Equivalent | OSTEOIMPLANT TECHNOLOGY, INC. |
| K990369 | SYNERGY CEMENTED HIP STEM | Mar 12, 1999 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K990032 | MODULAR PROTUSIO CUP | Feb 18, 1999 | Substantially Equivalent | BIOMET, INC. |
| K984154 | APF POROUS COATED LINE EXTENSION | Feb 11, 1999 | Substantially Equivalent | BIOMET, INC. |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K983226 | OSTEONICS X CEMENTED HIP STEM SERIES | Dec 04, 1998 | Substantially Equivalent | OSTEONICS CORP. |
| K983128 | IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY | Dec 03, 1998 | Substantially Equivalent | IMPLEX CORP. |
| K983710 | 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH | Dec 02, 1998 | Substantially Equivalent | BIOMET, INC. |
| K983136 | DEPUY LUSTER STEM | Nov 25, 1998 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION | Nov 20, 1998 | Substantially Equivalent | ORTHOPAEDIC BIOSYSTEMS, LTD. |
| K982918 | DEPUY C-STEM SYSTEM | Oct 05, 1998 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K982670 | CONTEMPORARY ACETABULAR COMPONENT | Oct 02, 1998 | Substantially Equivalent | HOWMEDICA CORP. |
| K982598 | OTI FEMORAL LOCK TOTAL HIP SYSTEM | Oct 02, 1998 | Substantially Equivalent | OSTEOIMPLANT TECHNOLOGY, INC. |
| K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS | Sep 22, 1998 | Substantially Equivalent | OSTEONICS CORP. |
| K981855 | PRINCE MEDICAL CEMENT PLUG | Aug 10, 1998 | Substantially Equivalent | PRINCE MEDICAL, INC. |
| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Jun 26, 1998 | Substantially Equivalent | HOWMEDICA, INC. |
| K980843 | EXETER INTRAMEDULLARY BONE PLUG | Jun 02, 1998 | Substantially Equivalent | HOWMEDICA, INC. |
| K980794 | DUAL LOCK HIP STEM | May 20, 1998 | Substantially Equivalent | DEPUY, INC. |
| K980513 | ARTICUL/EZE FEMORAL HEADS | Apr 14, 1998 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K980486 | IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM | Apr 14, 1998 | Substantially Equivalent | IMPLEX CORP. |
| K980286 | ULTIMA ACETABULAR ROOF REINFORCEMENT RING | Apr 03, 1998 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K974558 | SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM | Mar 04, 1998 | Substantially Equivalent | BIOMET, INC. |
| K972791 | ENCORE LINEAR HIP | Jan 12, 1998 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K973809 | FOUNDATION FRACTURE STEM | Jan 02, 1998 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K974054 | DISTAL CENTRALIZER, EXETER II HIP SYSTEM | Dec 23, 1997 | Substantially Equivalent | HOWMEDICA, INC. |
| K973453 | TORNIER CEMENT RESTRICTOR | Dec 09, 1997 | Substantially Equivalent | TORNIER |
| K971681 | SMC FEMORAL HIP COMPONENT | Dec 04, 1997 | Substantially Equivalent | SIGNAL MEDICAL CORP. |
| K973296 | EXTEND HIP STEM | Nov 24, 1997 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K972995 | THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM | Nov 10, 1997 | Substantially Equivalent | CORIN U.S.A. |
| K972961 | STELKAST BIPOLAR SYSTEM | Nov 04, 1997 | Substantially Equivalent | STELKAST COMPANY |
| K972928 | KERBOULL CROSS | Nov 03, 1997 | Substantially Equivalent for Some Indications | HOWMEDICA, INC. |
| K972792 | DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS | Oct 16, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K972641 | DUAL OFFSET PERFECTA IMC HIP STEM | Oct 09, 1997 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K972460 | OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) | Sep 25, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM | Sep 11, 1997 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K971890 | RECOVERY PROTRUSIO CAGE | Aug 07, 1997 | Substantially Equivalent | BIOMET, INC. |
| K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED | Aug 06, 1997 | Substantially Equivalent | IMPLEX CORP. |
| K971581 | HEMISPHERE CEMENTED CUP | Jul 18, 1997 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K963612 | DURATION STABILIZED UHMWPE | Jun 11, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K970697 | OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM | Apr 24, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K970194 | PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT | Apr 14, 1997 | Substantially Equivalent | STELKAST COMPANY |
| K965019 | THE C-FIT FEMORAL HIP SYSTEM | Mar 25, 1997 | Substantially Equivalent | CORIN U.S.A. |
| K964003 | METAGEN ALL POLY ACETABULAR CUP SYSTEM | Mar 21, 1997 | Substantially Equivalent | METAGEN, L.L.C. |
| K970351 | GLOBAL TAPER SPECTRON HIP STEMS | Feb 28, 1997 | Substantially Equivalent | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| K964795 | CEMENTED CALCAR REPLACEMENT FEMORAL STEM | Feb 19, 1997 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K964655 | UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE | Feb 06, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K963671 | OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP | Feb 03, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K962468 | HEDROCEL ACETABULAR RESTRICTOR | Feb 03, 1997 | Substantially Equivalent | IMPLEX CORP. |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Jan 16, 1997 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K963109 | HERITAGE HIP SYSTEM | Jan 09, 1997 | Substantially Equivalent | ZIMMER, INC. |
| K964218 | PERFECTA PLASMA SPRAY HIP STEM | Jan 08, 1997 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K964262 | EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD | Dec 27, 1996 | Substantially Equivalent | EXACTECH, INC. |
| K963486 | REVISION HIP SYSTEM | Nov 27, 1996 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K963313 | EXACTECH ALL POLY ACETABULAR CUP | Nov 14, 1996 | Substantially Equivalent | EXACTECH, INC. |
| K963206 | S-ROM HIP SYSTEM - LOCKING PLUG | Oct 17, 1996 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K955137 | IM C-MENT ACETABULAR CAP | Oct 10, 1996 | Substantially Equivalent | IMPLANT IDEAS, LLC. |
| K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX | Oct 03, 1996 | Substantially Equivalent | ENDOTEC, INC. |
| K961304 | AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM | Oct 01, 1996 | Substantially Equivalent | EXACTECH, INC. |
| K962560 | VITALITY HIP STEM | Sep 19, 1996 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K960984 | SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS | Sep 17, 1996 | Substantially Equivalent | BIOMET, INC. |
| K960647 | OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS | Sep 17, 1996 | Substantially Equivalent | OSTEOIMPLANT TECHNOLOGY, INC. |
| K962267 | PERFECTA PS REVISION STEM | Sep 10, 1996 | Substantially Equivalent for Some Indications | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K962086 | CPS, CEMENTED CUP SYSTEM | Aug 07, 1996 | Substantially Equivalent | ARTOS MEDICAL PRODUCTS GMBH |
| K961899 | CPS, CEMENTED HIP SYSTEM | Aug 01, 1996 | Substantially Equivalent | ARTOS MEDICAL PRODUCTS GMBH |
| K960278 | COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT | Jul 25, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K960658 | COLLARLESS POLISHED TAPER HIP PROSTHESIS | Jul 16, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K961799 | NATURAL HIP SYSTEM - DRG HIP STEM | Jul 15, 1996 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K961619 | DEPUY ENDURANCE CALCAR HIP PROSTHESIS | Jul 12, 1996 | Substantially Equivalent | DEPUY, INC. |
| K960258 | NATURAL HIP SYSTEM | Jul 12, 1996 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K961890 | FOUNDATION 9MM FORGED CEMENTED STEM | Jun 14, 1996 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K960025 | PROTEK LOW PROFILE ACETABULAR CUP | Jun 07, 1996 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K960678 | BURCH/SCHNEIDER REINFORCEMENT CAGE | May 03, 1996 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K960626 | MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) | Apr 18, 1996 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K954598 | OSTEONICS OFFSET HIP STEMS | Apr 04, 1996 | Substantially Equivalent | OSTEONICS CORP. |
| K960302 | CONSENSUS ACETABULAR SHELL, ALL UHMWPE | Apr 01, 1996 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K960340 | CONSENSUS APEX DOME HOLE PLUG | Mar 15, 1996 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K960339 | CONSENSUS 22MM COCRMO FEMORAL HEAD | Feb 21, 1996 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K960156 | CONSENSUS 32MM COCRMO FEMORAL HEAD | Feb 21, 1996 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K960151 | CONSENSUS 26MM COCRMO FEMORAL HEAD | Feb 21, 1996 | Substantially Equivalent | U.S. MEDICAL PRODUCTS, INC. |
| K955620 | PRIME CEMENTED CALCAR FEMORAL STEMS | Feb 20, 1996 | Substantially Equivalent | ORTHOPAEDIC INNOVATIONS, INC. |
| K955473 | GAMMA SYSTEM | Feb 16, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K955296 | LINK MP RECONSTRUCTION HIP | Feb 14, 1996 | Substantially Equivalent | LINK AMERICA, INC. |
| K953202 | P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT | Jan 31, 1996 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K953200 | ULTIMA SIZE 0 CEMENTED FEMORAL STEM | Jan 31, 1996 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K952859 | ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT | Jan 31, 1996 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K955354 | ALTERNATIVE STERILIZATION PROCESS | Jan 24, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K954744 | ZCH ALPHA SYSTEM | Jan 23, 1996 | Substantially Equivalent | ZIMMER, INC. |
| K952970 | HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM | Jan 17, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K952731 | TOWNLEY ALL POLY ACETABULAR CUP | Dec 28, 1995 | Substantially Equivalent | BIOLOGICALLY ORIENTED PROSTHESES |
| K945774 | BETA FEMORAL HIP STEM | Dec 28, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K935585 | APR ACETABULAR INSERTS IOI BIPOLAR | Dec 13, 1995 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K954219 | REALITY LONG STEM HIP SYSTEM | Dec 04, 1995 | Substantially Equivalent | KINAMED, INC. |
| K951139 | ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) | Nov 22, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K954262 | NEXUS II FEMORAL COMPONENT | Nov 03, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K953578 | PROTEK ACETABULAR ROOF REINFORCEMENT RING | Oct 30, 1995 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K953033 | PRIME CEMENTED SMALL FEMORAL STEM | Sep 13, 1995 | Substantially Equivalent | ORTHOPAEDIC INNOVATIONS, INC. |
| K953025 | SLT 28MM XXL FEMORAL HEAD | Sep 08, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K952629 | NEXFLEX TOTAL HIP SYSTEM | Sep 08, 1995 | Substantially Equivalent | NEXMED, INC. |
| K934857 | HSS FEMORAL COMPONENTS | Jul 18, 1995 | Substantially Equivalent | HOSPITAL FOR SPECIAL SURGERY |
| K952191 | FORGED CEMENTED STEM | Jul 17, 1995 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K935263 | FOUNDATION POROUS STEM | Jul 11, 1995 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K952461 | ENDO PROSTHESIS FEMORAL HEAD | Jun 30, 1995 | Substantially Equivalent | STELKAST COMPANY |
| K951726 | S-ROM ZTP UHMWPE ACETABULAR CUP | Jun 21, 1995 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K950418 | ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) | Jun 15, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K951084 | S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS | May 31, 1995 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K945574 | OSTEONICS(R) CCR HIP STEM SERIES | May 30, 1995 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K950312 | ALPHA SYSTEM | May 17, 1995 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K943696 | ALL POLYETHYLENE CEMENTED ACETABULAR CUP | May 17, 1995 | Substantially Equivalent | DEPUY, INC. |
| K950761 | INDEX ACETABULAT COMPONENT | May 02, 1995 | Substantially Equivalent | BIOMET, INC. |
| K945115 | MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS | May 02, 1995 | Substantially Equivalent | BIOMET, INC. |
| K944792 | ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE) | Apr 26, 1995 | Substantially Equivalent | ZIMMER, INC. |
| K940328 | PRIME CEMENTED HIP SYSTEM | Apr 07, 1995 | Substantially Equivalent for Some Indications | ORTHOPAEDIC INNOVATIONS, INC. |
| K946371 | PROVIDENT HP SYSTEM | Apr 05, 1995 | Substantially Equivalent | STELKAST COMPANY |
| K935449 | FOUNDATION NON-POROUS STEM | Mar 30, 1995 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K940307 | HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT | Jan 19, 1995 | Substantially Equivalent | HOWMEDICA, INC. |
| K942537 | PARAMOUNT CEMENTED HIP STEM PROTHESIS | Jan 09, 1995 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K943549 | RESTORATION ACETABULAR CUP | Dec 19, 1994 | Substantially Equivalent | OSTEONICS CORP. |
| K930771 | PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM | Nov 30, 1994 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K942370 | DEPUY CEMENTED HIP PROSTHESIS | Nov 10, 1994 | Substantially Equivalent | DEPUY, INC. |
| K936127 | HOWMEDICA PREMIUM FEMORAL COMPONENT | Oct 26, 1994 | Substantially Equivalent | HOWMEDICA, INC. |
| K936126 | HOWMEDICS DRG FEMORAL COMPONENT | Oct 20, 1994 | Substantially Equivalent for Some Indications | HOWMEDICA, INC. |
| K943302 | AML TRI-LOCK REPLACEMENT LINER SYSTEM | Oct 14, 1994 | Substantially Equivalent | DEPUY, INC. |
| K942966 | AML TRILOCK REPLACEMENT LINER SYSTEM | Oct 14, 1994 | Substantially Equivalent | DEPUY, INC. |
| K941617 | APR ACETABULAR INSERT | Oct 06, 1994 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K942406 | OPTION SHELL | Oct 05, 1994 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K942611 | FOUNDATION ALL POLY CUP | Sep 28, 1994 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K941486 | INTEGRITY TOTAL HIP SYSTEM, NON-POROUS | Sep 20, 1994 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K930275 | PRECISION OSTEOLOCK ACETABULAR COMPONENT | Sep 01, 1994 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K935951 | KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM | Jul 18, 1994 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K935206 | KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION | Jul 13, 1994 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K936214 | CS-PLUS STEM | Jun 15, 1994 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K936132 | EXETER ALL PLASTIC ACETABULAR COMPONENT | Jun 14, 1994 | Substantially Equivalent | HOWMEDICA, INC. |
| K932481 | SL-PLUS AND SLR-PLUS | Jun 08, 1994 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K933281 | S.O.S. PROXIMAL FEMUR | Jun 07, 1994 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K936043 | FOUNDATION POROUS ACETABULAR COMPONENT | Jun 03, 1994 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K934169 | FOUNDATION ALL POLY CUP | May 03, 1994 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K932574 | RMHS POROUS DISTAL SLEEVE | Mar 10, 1994 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K933561 | OSTEONICS OMNIFIT FORGED HIP STEM SERIES | Mar 09, 1994 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K935012 | BIOMETRIC TOTAL HIP SYSTEM | Mar 07, 1994 | Substantially Equivalent | OSTEO-TECHNOLOGY INTL., INC. |
| K930187 | OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS | Mar 03, 1994 | Substantially Equivalent | OSTEONICS CORP. |
| K933875 | PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE | Mar 01, 1994 | Substantially Equivalent | HOWMEDICA CORP. |
| K903630 | PRECISION OSTEOFLEX FEMORAL COMPONENT | Feb 23, 1994 | Substantially Equivalent | HOWMEDICA CORP. |
| K930460 | HOWMEDICA REVISION HIP SYSTEM | Feb 22, 1994 | Substantially Equivalent | HOWMEDICA CORP. |
| K930223 | HOWMEDICA ACETABULAR SHELL | Feb 22, 1994 | Substantially Equivalent | HOWMEDICA CORP. |
| K926229 | APC FEMORAL COMPONENT | Feb 22, 1994 | Substantially Equivalent | HOWMEDICA CORP. |
| K923243 | PERFECTA TOTAL HIP SYSTEM | Jan 07, 1994 | Substantially Equivalent | ORTHOMET, INC. |
| K930812 | APR FEMORAL HIP COMPONENT | Nov 17, 1993 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K925866 | CENATOR TOTAL HIP SYSTEM | Sep 23, 1993 | Substantially Equivalent | CORIN ORTHOPEDIC PRODUCTS |
| K930108 | RMHS POROUS DISTAL SLEEVE | Sep 21, 1993 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K925201 | EXACTECH FEMORAL STEM | Jun 15, 1993 | Substantially Equivalent | EXACTECH, INC. |
| K926323 | H-110 ACETABULAR CUP SYSTEM | May 26, 1993 | Substantially Equivalent | IMPLEX CORP. |
| K905262 | BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH | May 19, 1993 | Substantially Equivalent for Some Indications | ENDOTEC, INC. |
| K925348 | IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM | May 12, 1993 | Substantially Equivalent | IMPLEX CORP. |
| K915594 | STABILITY HIP FEMORAL COMPONENT | Apr 14, 1993 | Substantially Equivalent | DEPUY, INC. |
| K923275 | RMHS MONOLITHIC FEMORAL COMPONENT | Apr 08, 1993 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K922847 | PERFECTA TOTAL HIP SYSTEM | Apr 06, 1993 | Substantially Equivalent | ORTHOMET, INC. |
| K911058 | TECHMEDICA CAD/CAM CUSTOM HIP | Feb 23, 1993 | Substantially Equivalent | TECHMEDICA, INC. |
| K924323 | THE UNIVERSAL BONE CEMENT RESISTOR | Feb 12, 1993 | Substantially Equivalent | BIODYNAMIC TECHNOLOGIES, INC. |
| K922871 | UNIFIT FEMORAL STEM | Feb 12, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K922866 | OTI BONE PLUG | Feb 12, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K922864 | MUELLER TYPE FEMORAL STEM | Feb 12, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K922863 | EUROSTEM HIP PROTHESIS SYSTEM | Feb 12, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K922862 | CHARNLEY TYPE HIP PROTHESIS | Feb 12, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K922860 | AUSTIN-MOORE TYPE HIP PROSTHESIS | Feb 12, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K925895 | ETEX HIP REPLACEMENT SYSTEM | Feb 09, 1993 | Substantially Equivalent | ETEX CO. |
| K922733 | PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP | Feb 09, 1993 | Substantially Equivalent | ORTHOMET, INC. |
| K922645 | LSF ANATOMIC CEMENTED HIP | Jan 07, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K914078 | DEPUY HIP PROSTHESIS | Jan 07, 1993 | Substantially Equivalent | DEPUY, INC. |
| K924115 | ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS | Nov 24, 1992 | Substantially Equivalent | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K920739 | S-ROM TOTAL HIP REPLACEMENT SYSTEM | Nov 24, 1992 | Substantially Equivalent for Some Indications | JOINT MEDICAL PRODUCTS CORP. |
| K923898 | C-FIT CEMENTED HIP STEM | Nov 04, 1992 | Substantially Equivalent | TURNKEY INTERGRATION USA, INC. |
| K915500 | LESTER PRESS FIT HIP PROSTHESIS | Oct 20, 1992 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K922421 | KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP | Oct 15, 1992 | Substantially Equivalent | KINAMED, INC. |
| K922503 | HOWMEDICA(R) HNR SYSTEM | Sep 21, 1992 | Substantially Equivalent | HOWMEDICA CORP. |
| K914675 | MODULAR FEMORAL HEAD WITH OFFSET TRUNION | Aug 07, 1992 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K922008 | CDH HIP SYSTEM | Jul 30, 1992 | Substantially Equivalent | HOWMEDICA, PFIZER MEDICAL TECHNOLOGY GROUP |
| K914878 | ZIRCONIUM ALLOY FRMORAL HEAD | Jul 30, 1992 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K920430 | MODULAR ACETABULAR CUP SYSTEM | Jul 21, 1992 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K920640 | FULL HEMISPHERE RING-LOC LINER | Jun 30, 1992 | Substantially Equivalent | BIOMET, INC. |
| K920639 | RX 90 ACETABULAR COMPONENT SYSTEM | Jun 30, 1992 | Substantially Equivalent | BIOMET, INC. |
| K921383 | PRECISION STRATA TOTAL HIP STEM | Jun 25, 1992 | Substantially Equivalent | HOWMEDICA CORP. |
| K920286 | DEPUY TOTAL HIP BALLS - ION IMPLANTATION | Apr 21, 1992 | Substantially Equivalent | DEPUY, INC. |
| K920250 | OSTEONICS MICROSURFACED CDH HIP STEM | Apr 20, 1992 | Substantially Equivalent | STRYKER CORP. |
| K920161 | BIOMET NTS FEMORAL COMPONENTS | Apr 13, 1992 | Substantially Equivalent | BIOMET, INC. |
| K920021 | LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP | Mar 25, 1992 | Substantially Equivalent | IMPLANT TECHNOLOGY, INC. |
| K920317 | S-ROM LF FEMORAL HEAD | Mar 19, 1992 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K920003 | DRG CEMETED STEM | Mar 13, 1992 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K915795 | PERFECTA PDA TOTAL HIP SYSTEM | Mar 04, 1992 | Substantially Equivalent | ORTHOMET, INC. |
| K915216 | SOLUTION SYSTEM CUP | Feb 11, 1992 | Substantially Equivalent | DEPUY, INC. |
| K911802 | PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP | Jan 02, 1992 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K914406 | PT II DISTAL CEMENT SPACER | Dec 20, 1991 | Substantially Equivalent | OSTEONICS CORP. |
| K913231 | S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD | Dec 20, 1991 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K912712 | BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS | Dec 20, 1991 | Substantially Equivalent | BIOMET, INC. |
| K913634 | APR II HIP SYSTEM | Dec 16, 1991 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K913874 | INFINITY(TM) MICROTAPER HIP SYSTEM | Nov 27, 1991 | Substantially Equivalent | DOW CORNING WRIGHT |
| K913812 | OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES | Nov 22, 1991 | Substantially Equivalent | OSTEONICS CORP. |
| K913649 | MODULAR CALCAR REPLACEMENT | Nov 13, 1991 | Substantially Equivalent | ZIMMER, INC. |
| K913616 | LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP | Nov 07, 1991 | Substantially Equivalent | IMPLANT TECHNOLOGY, INC. |
| K913246 | HYBRID FIT TOTAL HIP SYSTEM | Oct 18, 1991 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K913208 | APR II NON-POROUS HIP STEM | Oct 11, 1991 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K913060 | NATURAL POROUS HIP SYSTEM | Oct 11, 1991 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K912593 | MODULAR HIP SYSTEM | Oct 02, 1991 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K912916 | APR COLLAR SPACER | Sep 27, 1991 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K912426 | UHMWP ACETABULAR COMPONENT | Aug 21, 1991 | Substantially Equivalent | HOWMEDICA CORP. |
| K911890 | OSTEONICS(R) PRT HIP STEM SERIES | Jul 26, 1991 | Substantially Equivalent | OSTEONICS CORP. |
| K904737 | GROSS HIP FEMORAL COMPONENT | Jul 26, 1991 | Substantially Equivalent | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K911718 | M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST) | Jul 16, 1991 | Substantially Equivalent | BIOMET, INC. |
| K911685 | RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP | Jul 15, 1991 | Substantially Equivalent | BIOMET, INC. |
| K910093 | FUTURA FEMORAL HIP STEM | Jul 01, 1991 | Substantially Equivalent | O'TEC CORP. |
| K911684 | BIOMET COBALT-CHROME FEMORAL COMPONENTS | Jun 27, 1991 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K911052 | NEXUS(TM) FEMORAL HIP STEM | Jun 17, 1991 | Substantially Equivalent | DOW CORNING WRIGHT |
| K905298 | TITAN TOTAL HIP DEVICE | Jun 17, 1991 | Substantially Equivalent | DR. JEAN-MARC GUICHET |
| K910836 | LIMA COLLARED CL STEM | Jun 14, 1991 | Substantially Equivalent | LIMA INTL. CORP. |
| K910352 | BIOPRO METAL BACKED CEMENTED ACETABULAR CUP | Jun 13, 1991 | Substantially Equivalent | BIOPRO, INC. |
| K910869 | HOWMEDICA(R) CEMETED FEMORAL COMPONENT | May 23, 1991 | Substantially Equivalent | HOWMEDICA CORP. |
| K905258 | S-ROM OBLONG ACETABULAR CUP | May 21, 1991 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K910662 | PS OMNIFIT NORMALIZED HIP STEM SERIES | May 13, 1991 | Substantially Equivalent | OSTEONICS CORP. |
| K910922 | OSTEONICS CDH HIP STEM | Apr 05, 1991 | Substantially Equivalent | OSTEONICS CORP. |
| K910988 | OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES | Mar 26, 1991 | Substantially Equivalent | OSTEONICS CORP. |
| K905408 | NEXUS ACETABULAR CUP | Mar 01, 1991 | Substantially Equivalent | DOW CORNING WRIGHT |
| K905275 | OSTEONICS(R) MPSS HIP STEM SERIES | Jan 28, 1991 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K905406 | OSTEONICS HIP REVISION WEDGES | Jan 04, 1991 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K905158 | OSTEONICS(R) 6011 HIP STEM SERIES | Jan 04, 1991 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K904207 | BIOPRO TRINITY ACETABULAR CUP | Jan 04, 1991 | Substantially Equivalent for Some Indications | BIOPRO, INC. |
| K903938 | C FIT CUP | Jan 04, 1991 | Substantially Equivalent for Some Indications | ORTHOPEDIC SYSTEMS, INC. |
| K896851 | PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC | Jan 01, 1991 | Substantially Equivalent | LIMA INTL. CORP. |
| K904919 | PROXIMAL FEMUR REPLACEMENT STEM | Dec 05, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K904844 | PRECISION HIP STEM WITH ADDITIONAL STEM SIZES | Dec 05, 1990 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K903957 | VSP HIP STEM | Nov 26, 1990 | Substantially Equivalent for Some Indications | TURNKEY INTERGRATION USA, INC. |
| K903635 | PERFECTA TOTAL HIP SYSTEM | Nov 09, 1990 | Substantially Equivalent | ORTHOMET, INC. |
| K903636 | OSTEONICS DRM ACETABULAR COMPONENT | Oct 30, 1990 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K903116 | RM ISOELASTIC BEVELLED ACETABULAR CUP | Oct 23, 1990 | Substantially Equivalent | ROBERT MATHYS CO. |
| K903362 | OSTEOLOCK(TM) ACETABULAR CUP | Oct 22, 1990 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K904351 | FOCUS COBALT CHROMIUM TOTAL HIP | Oct 17, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K903234 | F-19 TOTAL HIP PROSTHESIS | Oct 10, 1990 | Substantially Equivalent | MED-TEK CORP. |
| K902961 | DIMENSION-II TOTAL HIP SYSTEM | Oct 03, 1990 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K900261 | ACSYS PREFIX ACETABULAR CUP PROSTHESIS | Sep 14, 1990 | Substantially Equivalent | 3M COMPANY |
| K902621 | SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT | Sep 11, 1990 | Substantially Equivalent | LIMA INTL. CORP. |
| K901451 | F-20 CEMENTED METAL-BACKED ACETABULAR CUP | Aug 31, 1990 | Substantially Equivalent for Some Indications | MED-TEK CORP. |
| K902436 | HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE | Aug 29, 1990 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K902396 | MODIFIED DEPUY ACETABULAR CUP SYSTEM | Aug 24, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K902395 | MODIFIED AML + ACETABULAR CUP SYSTEM | Aug 24, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K902727 | LSF CEMENTED FEMORAL HIP | Aug 09, 1990 | Substantially Equivalent | IMPLANT TECHNOLOGY, INC. |
| K902279 | KM-5 METAL BACKED ACETABULAR CUP | Aug 09, 1990 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K903243 | MULLER-TYPE FEMORAL COMPONENT | Jul 30, 1990 | Substantially Equivalent | ONYX MEDICAL CORP. |
| K903242 | ACETABULAR CUP | Jul 30, 1990 | Substantially Equivalent | ONYX MEDICAL CORP. |
| K902137 | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT | Jun 26, 1990 | Substantially Equivalent | JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
| K901480 | F-20 TOTAL HIP PROSTHESIS | Jun 12, 1990 | Substantially Equivalent | MED-TEK CORP. |
| K901460 | LSF(TM) TOTAL HIP SYSTEM | May 22, 1990 | Substantially Equivalent for Some Indications | IMPLANT TECHNOLOGY, INC. |
| K901328 | DOMED AND FINNED ACETABULAR COMPONENT | May 22, 1990 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K901364 | HGP II TOTAL HIP FEMERAL STEM | May 18, 1990 | Substantially Equivalent for Some Indications | ZIMMER, INC. |
| K901087 | MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS | May 07, 1990 | Substantially Equivalent | DEPUY, INC. |
| K900832 | MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. | May 04, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K901297 | EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP | May 02, 1990 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K900438 | MC2P ACETABULAR COMPONENT | Apr 18, 1990 | Substantially Equivalent | OSTEONICS CORP. |
| K900257 | MULLER TYPE ACETABULAR CUP | Apr 18, 1990 | Substantially Equivalent | LIMA INTL. CORP. |
| K901240 | ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED | Mar 26, 1990 | Substantially Equivalent | MED-TEK CORP. |
| K900836 | OSTEONICS ECSI HIP STEM SERIES | Mar 21, 1990 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K900891 | MODIFIED AML + ACETABULAR CUP PROSTHESIS | Mar 12, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K895036 | TITANIUM MODULAR MODULAR COLLARLESS HIP | Jan 31, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K895035 | TITANIUM MODULAR COLLARED HIP PROSTHESIS | Jan 31, 1990 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K896325 | QUANTUM HIP STEM | Jan 29, 1990 | Substantially Equivalent | DEPUY, INC. |
| K895636 | DIMENSION REVISION TOTAL HIP SYSTEM | Dec 14, 1989 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K884890 | LORD L.F.R. TOTAL HIP SYSTEM | Dec 08, 1989 | Substantially Equivalent | HOWMEDICA CORP. |
| K893821 | ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST. | Nov 06, 1989 | Substantially Equivalent | KINAMED, INC. |
| K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION | Oct 13, 1989 | Substantially Equivalent for Some Indications | ORTHOPEDIC SYSTEMS, INC. |
| K894298 | MODIFIED GEMINI ACETABULAR CUP | Sep 27, 1989 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K894149 | MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL | Sep 14, 1989 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K894148 | MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL | Sep 05, 1989 | Substantially Equivalent | HOWMEDICA CORP. |
| K894249 | UNIVERSAL CEMENTED CUP | Aug 03, 1989 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K885192 | APR COLLARED REVISION FEMORAL COMPONENT | Jun 22, 1989 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K891454 | EXETER II TOTAL HIP SYSTEM | Jun 07, 1989 | Substantially Equivalent | HOWMEDICA CORP. |
| K890742 | INTRAFORM TOTAL HIP SYSTEM | May 10, 1989 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K884027 | PERFECTA II/NON-COATED TOTAL HIP SYSTEM | Apr 07, 1989 | Substantially Equivalent | ORTHOMET, INC. |
| K885338 | AML BOWED FEMORAL HIP | Mar 15, 1989 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K890649 | OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST. | Mar 13, 1989 | Substantially Equivalent | OSTEONICS CORP. |
| K890054 | M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. | Feb 08, 1989 | Substantially Equivalent for Some Indications | PROTEK, INC. |
| K884888 | MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS | Dec 29, 1988 | Substantially Equivalent for Some Indications | PROTEK, INC. |
| K883618 | PERFECTA II TOTAL HIP SYSTEM | Dec 28, 1988 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K884432 | MODIFIED LSF TOTAL HIP SYSTEM | Dec 09, 1988 | Substantially Equivalent | IMPLANT TECHNOLOGY, INC. |
| K883941 | PROFORMA HIP SYSTEM | Nov 30, 1988 | Substantially Equivalent | ORTHOMET, INC. |
| K884457 | MODULAR COLLARED HJD TOTAL HIP SYSTEM | Nov 17, 1988 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K883724 | GEMINI FEMORAL HIP PROSTHESIS | Nov 16, 1988 | Substantially Equivalent | DEPUY, INC. |
| K882869 | TOWNLEY COX COMB ACETABULAR COMPONENT | Oct 14, 1988 | Substantially Equivalent for Some Indications | BIOPRO, INC. |
| K883460 | FOCUS TOTAL HIP SYSTEM | Oct 11, 1988 | Substantially Equivalent | DEPUY, INC. |
| K882146 | BIOPRO PC FEMORAL HIP COMPONENT | Aug 29, 1988 | Substantially Equivalent for Some Indications | BIOPRO, INC. |
| K882812 | OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM | Aug 08, 1988 | Substantially Equivalent | OSTEONICS CORP. |
| K880435 | PROFORMA/PS TOTAL HIP SYSTEM | Jun 29, 1988 | Substantially Equivalent | ORTHOMET, INC. |
| K881769 | HJD CALCAR REPLACEMENT PROSTHESIS | Jun 22, 1988 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K880269 | LCS FEMORAL HIP PROSTHESIS | May 06, 1988 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K881117 | RESUBMITTING OF HJD TOTAL HIP SYSTEM | Apr 29, 1988 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K871867 | ELITE MODULAR HIP SYSTEM | Apr 08, 1988 | Substantially Equivalent | THACKRAY USA |
| K880390 | INTRAFORM TOTAL HIP SYSTEM | Apr 05, 1988 | Substantially Equivalent | ORTHOMET, INC. |
| K881128 | TITANIUM FEMORAL HIP | Mar 21, 1988 | Substantially Equivalent | DEPUY, INC. |
| K880461 | PERFECTA TOTAL HIP SYSTEM | Mar 15, 1988 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K880004 | TOWNLEY COX COMB ACETABULAR CUP | Feb 18, 1988 | Substantially Equivalent | ORTHOMET, INC. |
| K871852 | COXA ACETABULAR CUP | Feb 18, 1988 | Substantially Equivalent | THACKRAY USA |
| K874619 | SPECTRON EF ACETABULAR COMPONENT | Feb 17, 1988 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K874616 | MOORE HIP PROSTHESIS FENESTRATED STEM | Jan 29, 1988 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K874599 | MOORE HIP PROSTHESIS SOLID STEM | Jan 29, 1988 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K874093 | SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP | Jan 27, 1988 | Substantially Equivalent | PROTEK, INC. |
| K873626 | FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM | Dec 31, 1987 | Substantially Equivalent for Some Indications | ORTHOPEDIC SYSTEMS, INC. |
| K873632 | HI-NEK TOTAL HIP | Dec 07, 1987 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K873857 | WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS | Dec 01, 1987 | Substantially Equivalent for Some Indications | DOW CORNING WRIGHT |
| K874229 | ANATOMIC TOTAL HIP | Nov 03, 1987 | Substantially Equivalent | ZIMMER, INC. |
| K873999 | PREMIER-TOTAL (TM) HIP | Oct 28, 1987 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K873585 | POROUS COATED ACETABULAR CUP | Oct 28, 1987 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K870922 | C.L.E. ACETABULAR CUP | Oct 28, 1987 | Substantially Equivalent | PROTEK, INC. |
| K872732 | MCCUTCHEN ACETABULAR CUP PROSTHESIS | Oct 01, 1987 | Substantially Equivalent | DOW CORNING WRIGHT |
| K864999 | KENNEDY STEM | Sep 09, 1987 | Substantially Equivalent | ALLO PRO CORP. |
| K872856 | BIOPRO 32MM BALL | Aug 17, 1987 | Substantially Equivalent | BIOPRO, INC. |
| K871402 | MURRAY/WELCH TOTAL HIP SYSTEM | Jul 16, 1987 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K871347 | WAGNER REVISIONAL FEMORAL HIP PROSTHESIS | Jul 01, 1987 | Substantially Equivalent | PROTEK, INC. |
| K871857 | HPS II CALCAR FEMORAL PROSTHESIS | Jun 23, 1987 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K871462 | PROSTHETIC - FEMORAL HIP COMPONENT | Jun 04, 1987 | Substantially Equivalent for Some Indications | LOUIS A. SERAFIN, JR., M.D. |
| K870235 | OMNIFIT II HIP PROSTHESES: CEMENT FIXATION | May 29, 1987 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K871510 | MODIFIED PROFILE HIP PMMA CEMENT SPACER | May 27, 1987 | Substantially Equivalent | DEPUY, INC. |
| K871401 | KIRSCHNER MODULAR HIP SYSTEM | May 18, 1987 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K870128 | HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) | May 13, 1987 | Substantially Equivalent for Some Indications | RICHARDS MEDICAL CO., INC. |
| K870699 | STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP | May 01, 1987 | Substantially Equivalent | DEPUY, INC. |
| K871299 | SDI TOTAL HIP SYSTEM | Apr 27, 1987 | Substantially Equivalent for Some Indications | ORTHOMET, INC. |
| K864857 | OPTI-FIX ACETABULAR COMPONENT | Mar 24, 1987 | Substantially Equivalent for Some Indications | RICHARDS MEDICAL CO., INC. |
| K870445 | THREADED ACETABULAR COMPONENT | Mar 20, 1987 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K870216 | MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS | Mar 20, 1987 | Substantially Equivalent for Some Indications | OSTEONICS CORP. |
| K861988 | MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY | Feb 11, 1987 | Substantially Equivalent | PROTEK, INC. |
| K863184 | PROFILE HIP ACETABULUM PROSTHESIS | Jan 15, 1987 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K861979 | AML II TITANIUM ACETABULUM PROSTHESIS | Jan 15, 1987 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K861433 | UNIVERSAL ACETABULAR COMPONENT | Oct 27, 1986 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K862234 | EXACTECH TOTAL HIP SYSTEM | Oct 15, 1986 | Substantially Equivalent for Some Indications | EXACTECH, INC. |
| K862225 | INTERNATIONAL TOTAL HIP SYSTEM | Jul 11, 1986 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K861930 | CM-6 TOTAL HIP SYSTEM | Jun 11, 1986 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K855017 | LSF* TOTAL HIP SYSTEM | Jun 11, 1986 | Substantially Equivalent for Some Indications | IMPLANT TECHNOLOGY, INC. |
| K861114 | MALLORY/HEAD - PF ACETABULAR COMPONENT | Apr 17, 1986 | Substantially Equivalent | BIOMET, INC. |
| K860002 | CONICAL COLLAR HIP PROSTHESIS POROUS COATED | Apr 01, 1986 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K855200 | MODULAR PRESS FIT (MPF) STEM | Apr 01, 1986 | Substantially Equivalent | DEPUY, INC. |
| K860701 | HPS II SMOOTH STEM | Mar 19, 1986 | Substantially Equivalent | DEPUY, INC. |
| K854465 | LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM | Feb 10, 1986 | Substantially Equivalent | LINK AMERICA, INC. |
| K853916 | P.M. HIP-FEMORAL PROSTHESIS | Dec 27, 1985 | Substantially Equivalent | ADVANCED BIOSEARCH ASSN. |
| K844050 | ARTHOPOR-ACETABULAR COMPONENT | Dec 06, 1985 | Substantially Equivalent for Some Indications | JOINT MEDICAL PRODUCTS CORP. |
| K853886 | P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM | Nov 25, 1985 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K854046 | CONICAL COLLAR HIP PROSTHESIS | Nov 19, 1985 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K853768 | MULLER SELF LOCKING TOTAL HIP | Nov 19, 1985 | Substantially Equivalent | PROTEK, INC. |
| K853408 | COLLAR LESS AML HIP | Nov 15, 1985 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K853169 | GT HIP PROSTHESIS FEMORAL COMPONENT | Oct 29, 1985 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K852839 | FREEMAN HIP | Oct 29, 1985 | Substantially Equivalent | ADVANCED BIOSEARCH ASSN. |
| K853655 | NEW JERSEY MODULAR FEMORAL HIP | Sep 19, 1985 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K844319 | KM-2 METAL-BACKED ACETABULAR CUP | Sep 19, 1985 | Substantially Equivalent for Some Indications | KIRSCHNER MEDICAL CORP. |
| K852517 | CLS HIP PROSTHESIS | Sep 18, 1985 | Substantially Equivalent | ADVANCED BIOSEARCH ASSN. |
| K851422 | S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP | Sep 18, 1985 | Substantially Equivalent | JOINT MEDICAL PRODUCTS CORP. |
| K852585 | POROUS APF/MODULAR FEMORAL COMPONENT | Aug 22, 1985 | Substantially Equivalent for Some Indications | BIOMET, INC. |
| K852546 | HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY | Aug 21, 1985 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K852153 | THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP | Aug 16, 1985 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K852705 | LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS | Aug 13, 1985 | Substantially Equivalent | WALDEMAR LINK GMBH & CO. KG |
| K844787 | BIOMETRIC TOTAL HIP SYSTEM | Apr 19, 1985 | Substantially Equivalent | BIOMEDICS |
| K844817 | MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM | Mar 12, 1985 | Substantially Equivalent | OSTEONICS CORP. |
| K844941 | CFE ACETABULAR CUP | Mar 05, 1985 | Substantially Equivalent | BIOMET, INC. |
| K845005 | BROOKER ACETABULAR CUP | Feb 21, 1985 | Substantially Equivalent | BIOMET, INC. |
| K844028 | LORD SCREW RING ACETABULAR COMPONENT | Feb 12, 1985 | Substantially Equivalent | HOWMEDICA CORP. |
| K843190 | HAP ACETABULAR CUP | Nov 16, 1984 | Substantially Equivalent | DEPUY, INC. |
| K843909 | TITANIUM HIP 1019 | Nov 15, 1984 | Substantially Equivalent | DEPUY, INC. |
| K842360 | DORR HIP PROSTHESIS FEMORAL COMPONENT | Oct 02, 1984 | Substantially Equivalent | CARBOMEDICS, INC. |
| K842906 | BIAS TOTAL HIP | Aug 24, 1984 | Substantially Equivalent | ZIMMER, INC. |
| K842202 | NEW JERSEY ACETABULAR COMPONENT & | Jul 20, 1984 | Substantially Equivalent | ENDOMEDICS, INC. |
| K834035 | UNIVERSAL SELF-ALIGNING ACETABULAR COM | Jun 19, 1984 | Substantially Equivalent | ORTHOPEDIC EQUIPMENT CO., INC. |
| K840643 | HARRIS-GALANTE POROUS TOTAL HIP SYS | Apr 17, 1984 | Substantially Equivalent | ZIMMER, INC. |
| K841391 | WEBER-STUHMER HIP PROSTHESIS STEM | Apr 13, 1984 | Substantially Equivalent | ALLO PRO CORP. |
| K840150 | TOTAL HIP FEMORAL COMPONENT | Feb 27, 1984 | Substantially Equivalent | ADVANCED BIOSEARCH ASSN. |
| K840357 | SSA HIP PROSTHESIS | Feb 17, 1984 | Substantially Equivalent | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
| K833881 | ACETABULAR SCREW RING | Jan 13, 1984 | Substantially Equivalent | MECRON MEDICAL PRODUCTS, INC. |
| K833912 | GALANTE FIBER METAL TOTAL HIP | Dec 22, 1983 | Substantially Equivalent | ZIMMER, INC. |
| K832958 | FREEMAN ACETABULAR CUP | Oct 04, 1983 | Substantially Equivalent | DEPUY, INC. |
| K832211 | DOSIMETRIC RELEASE OF GAMMA RADIATION | Sep 29, 1983 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K830361 | MMS ACETABULAR CUPS | Sep 29, 1983 | Substantially Equivalent | 3M COMPANY |
| K831884 | SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL | Sep 20, 1983 | Substantially Equivalent | RICHARDS MANUFACTURER CO. |
| K831373 | P.C.A. HIP SYSTEM | Aug 26, 1983 | Substantially Equivalent | HOWMEDICA CORP. |
| K831986 | METAL-BACKED ACE TABULAR CUP | Aug 08, 1983 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K831314 | INTERFERENCE MEDULLARY FIT -IMF-HIP | Jul 12, 1983 | Substantially Equivalent | DEPUY, INC. |
| K830948 | WEBER/STIIHMER FEMORAL HEAD PROSTHESIS | Jul 12, 1983 | Substantially Equivalent | ALLO PRO CORP. |
| K830314 | MILWAUKEE AUSTIN MOORE TOTAL HIP | Jun 24, 1983 | Substantially Equivalent | BIOMET, INC. |
| K830313 | CFE TOTAL HIP FEMORAL COMPONENT | May 25, 1983 | Substantially Equivalent | BIOMET, INC. |
| K830209 | LUS ACETABULAR COMPONENT | May 16, 1983 | Substantially Equivalent | BIOMET, INC. |
| K830857 | HARRIS A.R. C. ACETABULAR CUP | May 09, 1983 | Substantially Equivalent | HOWMEDICA CORP. |
| K830750 | CEMENTED 101 32 FEMORAL COMPONENT | May 02, 1983 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K830004 | POROCOAT DUAL-LOCK TOTAL HIP SYSTEM | Apr 19, 1983 | Substantially Equivalent | DEPUY, INC. |
| K830356 | TITANIUM M.E. MULLER TYPE TOTAL HIP | Mar 09, 1983 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K823724 | SPECTRON NECK REPLACEMENT PROSTHESIS | Mar 09, 1983 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K823723 | SPECTRON PROXIMAL FEMORAL PROSTHESIS | Mar 09, 1983 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K823727 | SPECTRON PRIMARY STEM FEMORAL PROSTHES | Mar 08, 1983 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K823722 | SPECTRON LONG, STRAIGHT FEMORAL PROSTHES | Mar 08, 1983 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K823729 | SPECTRON METAL BACK ACETABULAR COMPONENT | Jan 21, 1983 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K823728 | SPECTRON POLYETHYLENE ACCTUBULAR COMPON | Jan 21, 1983 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K823725 | SPECTRON PROTRUSIO CUP | Jan 21, 1983 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
| K823419 | HC 1M METALBACKED ACETABULAR CUP | Jan 17, 1983 | Substantially Equivalent | OSTEONICS CORP. |
| K822979 | CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES | Jan 14, 1983 | Substantially Equivalent | ALLO PRO CORP. |
| K821893 | ZIMMER METAL BACKED ACETABULAR CUP | Sep 14, 1982 | Substantially Equivalent | ZIMMER, INC. |
| K821714 | POROCOAT STANDARD METAL BACKED CUP | Aug 20, 1982 | Substantially Equivalent | DEPUY, INC. |
| K821713 | POROCOAT LOW PROFILE METAL BACKED CUP | Aug 20, 1982 | Substantially Equivalent | DEPUY, INC. |
| K821369 | TITANIUM AUFRANC-TURNER ATS HIP SYS | May 21, 1982 | Substantially Equivalent | HOWMEDICA CORP. |
| K821066 | CONTOUR II LINK SP TOTAL HIP PROSTHESIS | Apr 29, 1982 | Substantially Equivalent | C.R. BARD, INC. |
| K813600 | AUFRANC-TURNER TYPE ACETABULAR COMPON | Jan 22, 1982 | Substantially Equivalent | INTERMEDICS ORTHOPEDICS |
| K813089 | CEMENT RING | Nov 20, 1981 | Substantially Equivalent | BIOMET, INC. |
| K812801 | HIP STEM SYSTEM TITANIUM ALLOY | Oct 20, 1981 | Substantially Equivalent | OSTEONICS CORP. |
| K802342 | PROXIMAL INTERPHALANGEAL JOINT IMPLANT | Oct 14, 1981 | Substantially Equivalent | SUTTER BIOMEDICAL, INC. |
| K812182 | MIAMI, PROTRUSIO RING | Aug 18, 1981 | Substantially Equivalent | ZIMMER, INC. |
| K811293 | EFTEKHAR CENTRALIZING PLUG | Jun 24, 1981 | Substantially Equivalent | ZIMMER, INC. |
| K811151 | COLLARLESS TOTAL HIP FEMORAL COMP. SYS | May 15, 1981 | Substantially Equivalent | HOWMEDICA CORP. |
| K803126 | EXETER TOTAL HIP SYSTEM | Feb 10, 1981 | Substantially Equivalent | HOWMEDICA CORP. |
| K810120 | REINFORCED HIP CUP | Feb 04, 1981 | Substantially Equivalent | BIOMET, INC. |
| K803074 | FERNORAL HIP PROSTHESIS | Jan 08, 1981 | Substantially Equivalent | CINTOR ORTHOPAEDIC DIV. |
| K802627 | ORTRON 90* HIP PROSTHESIS | Dec 16, 1980 | Substantially Equivalent | CINTOR ORTHOPAEDIC DIV. |
| K802872 | AUFRANC-TURNER ATS TOTAL HIP SYSTEM | Dec 11, 1980 | Substantially Equivalent | HOWMEDICA CORP. |
| K800894 | DUPUY CEMENT RESTRICTOR TRIALS & INSTR. | May 02, 1980 | Substantially Equivalent | DEPUY, INC. |
| K800487 | 3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM | Apr 29, 1980 | Substantially Equivalent | 3M COMPANY |
| K790488 | INTERPLANTA SP TOTAL HIP PROSTHESIS | Mar 28, 1979 | Substantially Equivalent | WALDEMAR LINK GMBH & CO. KG |
| K780398 | CUP, ACETABULAR, LONG POSTERIOR WALL | Mar 21, 1978 | Substantially Equivalent | ORTHOPEDIC EQUIPMENT CO., INC. |
| K780317 | TOTAL HIP SYSTEM, HARRIS HD2 | Mar 06, 1978 | Substantially Equivalent | HOWMEDICA CORP. |
| K780052 | PROSTHESIS, DOUBLE CUP | Jan 20, 1978 | Substantially Equivalent | DEPUY, INC. |
| K770908 | PROSTHESIS, HIP, TRAPEZOIDAL-28 | May 23, 1977 | Substantially Equivalent | ZIMMER, INC. |
FEI Numbers
This FDA classification entry is associated with 231 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 231 registration numbers. Click on an entry to view related FDA registrations.