Product Code: PHX
FDA class 2
21 CFR 888.3660
Shoulder Prosthesis, Reverse Configuration
Orthopedic
The Reverse Configuration Shoulder Prosthesis is an orthopedic implant intended to relieve pain, replace the glenoid and humeral surfaces of the shoulder joint, and restore mobility in patients with grossly rotator cuff-deficient joints, severe arthropathy, or failed prior joint replacements with cuff deficiency. It is an FDA Class 2 device regulated under 21 CFR 888.3660, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PHX, and it is flagged as an implant. This device is not life-sustaining.
510(k)s
183
FEI Numbers
194
Registration Numbers
194
Unique Applicants
69
Years Active
22
Basic Information
- Product Code
- PHX
- Device Class
- FDA class 2
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 183 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243826 | SMR Reverse HP Shoulder System | Jul 03, 2025 | Substantially Equivalent | LimaCorporate S.p.A. |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | May 19, 2025 | Substantially Equivalent | restor3d |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | May 16, 2025 | Substantially Equivalent | Encore Medical, L.P. |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | Nov 25, 2024 | Substantially Equivalent | FH Industrie |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Oct 10, 2024 | Substantially Equivalent | Stryker Corporation (Tornier, S.A.S.) |
| K233482 | Equinoxe® Central Screw Baseplate System | Jul 18, 2024 | Substantially Equivalent | Exactech Inc. |
| K233481 | AltiVate Reverse® Glenoid | May 29, 2024 | Substantially Equivalent | Encore Medical, L.P. |
| K241043 | Augment Off-Axis Instrument System | May 15, 2024 | Substantially Equivalent | Fix Surgical |
| K240278 | Full Wedge Lateralized and Augmented Baseplates | May 15, 2024 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K234105 | Catalyst F1x Shoulder System | Apr 05, 2024 | Substantially Equivalent | Catalyst OrthoScience, Inc. |
| K233148 | Augment Off-Axis Instrument System | Mar 22, 2024 | Substantially Equivalent | Fix Surgical |
| K232265 | BLUEPRINT Patient Specific Instrumentation | Feb 21, 2024 | Substantially Equivalent | Tornier SAS |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | Nov 16, 2023 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K231911 | Glenoid Reconstruction System Full Wedge Baseplate | Nov 09, 2023 | Substantially Equivalent | Medacta International S.A. |
| K232583 | Catalyst R1 Reverse Shoulder System | Sep 20, 2023 | Substantially Equivalent | Catalyst OrthoScience, Inc. |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Sep 14, 2023 | Substantially Equivalent | Exactech, Inc |
| K232226 | ARROW Off-Centred Humeral Insert | Aug 29, 2023 | Substantially Equivalent | FH Industrie |
| K223801 | FX V135(TM) Shoulder Prosthesis | Jun 05, 2023 | Substantially Equivalent | FX Shoulder USA, Inc |
| K223655 | Catalyst R1 Reverse Shoulder System | May 09, 2023 | Substantially Equivalent | Catalyst OrthoScience, Inc. |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Apr 10, 2023 | Substantially Equivalent | Arthrex Inc. |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | Mar 15, 2023 | Substantially Equivalent | Biomet Manufacturing Corp. |
| K223211 | INHANCETM Shoulder System Humeral Stems and Stemless | Dec 02, 2022 | Substantially Equivalent | Depuy Ireland UC |
| K213459 | Glenoid Reconstruction System | Nov 23, 2022 | Substantially Equivalent | Medacta International S.A. |
| K222936 | Humeris® 135 Shoulder System | Nov 07, 2022 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K220914 | Tornier Perform Humeral System Fracture | Oct 14, 2022 | Substantially Equivalent | Tornier, Inc. |
| K221467 | INHANCETM Reverse Glenoid Peripheral Posts | Aug 31, 2022 | Substantially Equivalent | Depuy Ireland UC |
| K213349 | Catalyst R1 Reverse Shoulder System | Jun 23, 2022 | Substantially Equivalent | Catalyst OrthoScience, Inc |
| K213117 | FX V135 Shoulder Prosthesis | Jun 07, 2022 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K212737 | INHANCE Reverse Shoulder System | Apr 21, 2022 | Substantially Equivalent | Depuy Ireland UC |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Feb 25, 2022 | Substantially Equivalent | LimaCorporate S.p.A. |
| K202024 | ARROW Short Stem Humeral System | Nov 30, 2021 | Substantially Equivalent | FH Industrie |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Nov 18, 2021 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | Nov 17, 2021 | Substantially Equivalent | Arthrex Inc. |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | Nov 12, 2021 | Substantially Equivalent | Tornier, Inc. |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Nov 04, 2021 | Substantially Equivalent | Biomet Manufacturing Corp. |
| K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres | Oct 26, 2021 | Substantially Equivalent | Tornier, Inc. |
| K212710 | GLOBAL UNITE Platform Shoulder System | Sep 15, 2021 | Substantially Equivalent | DePuy Ireland UC |
| K211074 | Univers Revers Modular Glenoid System, Standard Augment Baseplates | Sep 02, 2021 | Substantially Equivalent | Arthrex Inc. |
| K210790 | Lateralized and Augmented Baseplates | Aug 25, 2021 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K210533 | Inset Reverse Total Shoulder System | Aug 20, 2021 | Substantially Equivalent | Shoulder Innovations, Inc. |
| K211553 | Tecomet Global Unite Short Stem Instrumentation | Aug 04, 2021 | Substantially Equivalent | Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc. |
| K211991 | Catalyst R1 Reverse Shoulder System | Jul 28, 2021 | Substantially Equivalent | Catalyst OrthoScience, Inc. |
| K203694 | DELTA XTEND Reverse Shoulder System | Jul 22, 2021 | Substantially Equivalent | DePuy Ireland UC |
| K210717 | Bone Screws dia. 5,0 mm | Jul 12, 2021 | Substantially Equivalent | LimaCorporate S.p.A. |
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Jun 24, 2021 | Substantially Equivalent | Arthrosurface Inc. |
| K210207 | Humeral Eccentric Reverse Metaphysis | Mar 26, 2021 | Substantially Equivalent | Medacta International SA |
| K203755 | Shoulder System - TiNbN Coating | Mar 02, 2021 | Substantially Equivalent | Medacta International SA |
| K210167 | DELTA XTEND Reverse Shoulder System | Feb 19, 2021 | Substantially Equivalent | DePuy Orthopaedics Inc. |
| K202232 | Comprehensive Vault Reconstruction System | Feb 19, 2021 | Substantially Equivalent | Biomet Manufacturing Corp. |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Feb 12, 2021 | Substantially Equivalent | Catalyst OrthoScience, Inc. |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | Feb 05, 2021 | Substantially Equivalent | Waldemar Link GmbH & Co. KG |
| K202098 | GLOBAL UNITE Platform Shoulder System | Nov 25, 2020 | Substantially Equivalent | DePuy Ireland UC |
| K200171 | SMR TT Augmented Glenoid System | Nov 19, 2020 | Substantially Equivalent | LimaCorporate S.p.A |
| K200895 | Univers Revers Modular Glenoid System, Half Augment Baseplate | Aug 13, 2020 | Substantially Equivalent | Arthrex Inc. |
| K193175 | Lateralized Glenosphere | Aug 11, 2020 | Substantially Equivalent | Medacta Inernational SA |
| K191146 | Humelock TiN Coated Glenosphere | Jul 15, 2020 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Apr 29, 2020 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K193373 | Comprehensive® Reverse Shoulder | Apr 15, 2020 | Substantially Equivalent | Biomet Inc. |
| K192967 | Medacta Shoulder System | Mar 25, 2020 | Substantially Equivalent | Medacta International, SA |
| K192855 | DELTA XTEND(TM) Reverse Shoulder System | Feb 24, 2020 | Substantially Equivalent | DePuy (Ireland) |
| K192799 | Glenoid Baseplate with Screw | Feb 21, 2020 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | Feb 20, 2020 | Substantially Equivalent | Exactech, Inc |
| K193099 | Anatomical Shoulder System | Jan 29, 2020 | Substantially Equivalent | Zimmer GmbH |
| K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Jan 10, 2020 | Substantially Equivalent | Arthrex Inc. |
| K191960 | Arthrex Univers Revers Modular Glenoid System | Dec 23, 2019 | Substantially Equivalent | Arthrex Inc. |
| K190738 | MyShoulder Placement Guides | Dec 13, 2019 | Substantially Equivalent | Medacta International SA |
| K190588 | Integra TITAN Reverse Shoulder System | Dec 02, 2019 | Substantially Equivalent | Integra LifeSciences Corporation |
| K191746 | SMR TT Augmented Glenoid System | Nov 22, 2019 | Substantially Equivalent | Limacorporate S.p.A |
| K192206 | 32mm Glenosphere and Humeral Cup | Oct 08, 2019 | Substantially Equivalent | FX Shoulder USA, Inc. |
| K192448 | Delta Xtend Revers Shoulder System | Oct 04, 2019 | Substantially Equivalent | DePuy(Ireland) |
| K191561 | Exactech Equinoxe Humeral Augmented Trays | Aug 20, 2019 | Substantially Equivalent | Exactech, Inc |
| K183077 | Delta Xtend Reverse Shoulder System | May 17, 2019 | Substantially Equivalent | DePuy (Ireland) |
| K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | Jan 30, 2019 | Substantially Equivalent | Tornier, Inc. |
| K181826 | Glenoid Polyaxial Non-locking Screws | Dec 10, 2018 | Substantially Equivalent | Medacta International SA |
| K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap | Oct 12, 2018 | Substantially Equivalent | Exactech, Inc. |
| K181999 | Integra TITAN Reverse Shoulder System | Oct 12, 2018 | Substantially Equivalent | Integra Lifesciences Corporation |
| K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | Sep 28, 2018 | Substantially Equivalent | Arthrex Inc. |
| K181611 | Comprehensive Reverse Shoulder System | Sep 24, 2018 | Substantially Equivalent | Biomet Manufacturing Corp |
| K180632 | Exactech Equinoxe Small Reverse Shoulder System | Jul 25, 2018 | Substantially Equivalent | Exactech Inc. |
| K173717 | Integra TITAN Reverse Shoulder System | Jun 21, 2018 | Substantially Equivalent | Integra LifeSciences Corporation |
| K173900 | Arthrex Univers Revers Modular Glenoid System | Apr 20, 2018 | Substantially Equivalent | Arthrex Inc. |
| K180089 | Medacta Shoulder System Short Humeral Diaphysis | Apr 05, 2018 | Substantially Equivalent | Medacta International SA |
| K172371 | Arthrex UNIVERS REVERS COATED BASEPLATE | Mar 22, 2018 | Substantially Equivalent | Arthrex, Inc. |
| K173411 | Comprehensive Segmental Revision System (SRS) | Feb 08, 2018 | Substantially Equivalent | Biomet Manufacturing Corp. |
| K171789 | ARROW Reverse Porous Glenoid | Jan 23, 2018 | Substantially Equivalent | Fournitures Hospitalieres Industrie |
| K170748 | GLOBAL UNITE Platform Shoulder System | Jan 11, 2018 | Substantially Equivalent | DePuy Ireland UC |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | Jan 03, 2018 | Substantially Equivalent | Biomet Manufacturing Corp |
| K173073 | AltiVate Anatomic to Reverse Conversion Module | Dec 26, 2017 | Substantially Equivalent | Encore Medical, L.P. |
| K170414 | Arthrex Univers Revers Apex Humeral Stems | Dec 14, 2017 | Substantially Equivalent | Arthrex Inc. |
| K171058 | Medacta Shoulder System: Threaded Glenoid Baseplate | Dec 13, 2017 | Substantially Equivalent | Medacta International SA |
| K172767 | Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid | Nov 30, 2017 | Substantially Equivalent | Zimmer, Inc. |
| K170452 | Medacta Shoulder System | Oct 05, 2017 | Substantially Equivalent | Medacta International SA |
| K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | Jun 01, 2017 | Substantially Equivalent | Zimmer GmbH |
| K163669 | Humeris Shoulder | May 17, 2017 | Substantially Equivalent | Fx Solutions |
| K162325 | Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw | Mar 06, 2017 | Substantially Equivalent | Exactech Inc |
| K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments | Feb 21, 2017 | Substantially Equivalent | LIMACORPORATE S.P.A. |
| K162726 | Exactech® Equinoxe® Preserve Stem | Feb 01, 2017 | Substantially Equivalent | EXACTECH INC |
| K162455 | Humelock Reversed Shoulder | Jan 17, 2017 | Substantially Equivalent | FX SOLUTIONS |
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Nov 15, 2016 | Substantially Equivalent | Tornier, Inc. |
| K161189 | Integra TITAN Reverse Shoulder System | Aug 25, 2016 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) | May 16, 2016 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K152966 | Aequalis Fx2 | Jan 14, 2016 | Substantially Equivalent | Tornier SAS |
| K150488 | Humelock II Reversible Shoulder System | Nov 13, 2015 | Substantially Equivalent | FX SOLUTIONS |
| K150568 | ARROW Humeral stems size 6 and 16 | Oct 29, 2015 | Substantially Equivalent | FOURNITURES HOSPITALIERES INDUSTRIE |
| K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere | May 14, 2015 | Substantially Equivalent | EXACTECH, INC. |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Mar 20, 2015 | Substantially Equivalent | Fournitures Hospitalieres Industrie |
| K142863 | Univers Rivers Shoulder Prosthesis System | Nov 25, 2014 | Substantially Equivalent | Arthrex, Inc. |
| K141345 | AEQUALIS FX2 | Nov 18, 2014 | Substantially Equivalent | Tornier SAS |
| K142139 | SMR 40MM GLENOSPHERE | Nov 07, 2014 | Substantially Equivalent | LIMACORPORATE S.P.A. |
| K141990 | ENCORE HUMERAL SHOULDER STEM | Nov 07, 2014 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K140478 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Aug 06, 2014 | Substantially Equivalent | Tornier SAS |
| K140082 | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM | Jul 18, 2014 | Substantially Equivalent | Tornier SAS |
| K140652 | POROUS COATED COMPREHENSIVE FRACTURE STEMS | Jul 03, 2014 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K141029 | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM | Jun 18, 2014 | Substantially Equivalent | TORNIER, INC. |
| K141006 | RSP HUMERAL SOCKET INSERT | Jun 05, 2014 | Substantially Equivalent | DJO GLOBAL |
| K133378 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | May 12, 2014 | Substantially Equivalent | ZIMMER, INC. |
| K140904 | RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 | May 06, 2014 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K130550 | RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW | Mar 24, 2014 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K130895 | REUNION RSA SHOULDER SYSTEM | Dec 27, 2013 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP |
| K132285 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Dec 05, 2013 | Substantially Equivalent | TORNIER, SAS |
| K131231 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | Oct 16, 2013 | Substantially Equivalent | Tornier SAS |
| K130390 | COMPREHENSIVE CONVERTIBLE GLENOID | Oct 09, 2013 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K131353 | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE | Oct 08, 2013 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K132239 | COMPREHENSIVE REVERSE SHOULDER SCREWS | Sep 06, 2013 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K131575 | EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT | Jul 03, 2013 | Substantially Equivalent | EXACTECH, INC. |
| K130661 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | May 09, 2013 | Substantially Equivalent | ZIMMER, INC. |
| K121067 | EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE | Dec 06, 2012 | Substantially Equivalent | EXACTECH, INC. |
| K122692 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS | Dec 03, 2012 | Substantially Equivalent | ZIMMER, INC. |
| K122442 | DEPUY CTA REVERSE SHOULDER SYSTEM | Sep 06, 2012 | Substantially Equivalent | DEPUY FRANCE |
| K121183 | COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS | Jul 26, 2012 | Substantially Equivalent | BIOMET CORPORATION |
| K112193 | ARROW REVERSE SHOULDER SYSTEM | Jul 12, 2012 | Substantially Equivalent | FOURNITURES HOSPITALIERES INDUSTRIE |
| K120374 | SEVIIN REVERSE SHOULDER | Jul 09, 2012 | Substantially Equivalent | INGEN ORTHOPEDICS LLC |
| K120739 | AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM | Jul 05, 2012 | Substantially Equivalent | TORNIER, INC. |
| K120174 | DEPUT DELTA XTEND REVERSE SHOULDER | Jun 11, 2012 | Substantially Equivalent | DEPUY FRANCE |
| K112144 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS | Mar 13, 2012 | Substantially Equivalent | TORNIER |
| K113254 | SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS | Feb 24, 2012 | Substantially Equivalent | LIMACORPORATE S.P.A. |
| K120121 | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE | Feb 16, 2012 | Substantially Equivalent | BIOMET, INC. |
| K113069 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY | Jan 11, 2012 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K113523 | LIMACORPORATE SMR REVERSE SHOULDER SYSTEM | Dec 20, 2011 | Substantially Equivalent | LIMACORPORATE S.P.A. |
| K113121 | COMPREHENSIVE REVERSE SHOULDER | Dec 16, 2011 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K112069 | RSP GLENOID BASEPLATE POROUS COATED | Nov 15, 2011 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K103251 | DUOCENTRIC REVERSED | Oct 28, 2011 | Substantially Equivalent | ASTON MEDICAL |
| K112615 | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM | Oct 11, 2011 | Substantially Equivalent | TORNIER, INC. |
| K111735 | REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER | Oct 03, 2011 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K111629 | TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 | Sep 16, 2011 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K110598 | SMR REVERSE SHOULDER SYSTEM | Aug 18, 2011 | Substantially Equivalent | LIMACORPORATE S.P.A. |
| K111061 | REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) | Jul 20, 2011 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K110599 | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM | Jun 14, 2011 | Substantially Equivalent | TORNIER, INC. |
| K110708 | EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... | Apr 01, 2011 | Substantially Equivalent | EXACTECH, INC. |
| K103208 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM | Jan 31, 2011 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | Dec 15, 2010 | Substantially Equivalent | DEPUY (IRELAND) |
| K102951 | EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) | Nov 04, 2010 | Substantially Equivalent | EXACTECH, INC. |
| K093803 | BIO-MODULAR REVERSE SHOLDER | Oct 19, 2010 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K101909 | EXACTECH EQUINOXE, PLATFORM FRACTURE STEM | Aug 02, 2010 | Substantially Equivalent | EXACTECH, INC. |
| K100741 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 | Aug 02, 2010 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K093275 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER | May 27, 2010 | Substantially Equivalent | EXACTECH, INC. |
| K100142 | AEQUALIS REVERSED SHOULDER PROSTHESIS | May 06, 2010 | Substantially Equivalent | TORNIER |
| K092900 | EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM | Jan 07, 2010 | Substantially Equivalent | EXACTECH, INC. |
| K092873 | REVERSE SHOULDER PROSTHESIS | Oct 27, 2009 | Substantially Equivalent | DJO SURGICAL |
| K082702 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY | Oct 10, 2008 | Substantially Equivalent | EXACTECH, INC. |
| K081016 | SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM | Sep 05, 2008 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K081059 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Jul 17, 2008 | Substantially Equivalent | TORNIER |
| K080642 | COMPREHENSIVE REVERSE SHOULDER | Jul 09, 2008 | Substantially Equivalent | BIOMET, INC. |
| K073688 | EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW | Feb 29, 2008 | Substantially Equivalent | EXACTECH, INC. |
| K073676 | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP | Jan 29, 2008 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K072804 | COMPREHENSIVE RS SHOULDER SYSTEM | Dec 12, 2007 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K071948 | AEQUALIS REVERSED ADAPTER | Oct 18, 2007 | Substantially Equivalent | TORNIER |
| K071379 | DELTA XTEND REVERSE SHOULDER MODULAR STEM | Sep 11, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K063569 | EQUINOXE REVERSE SHOULDER SYSTEM | Feb 23, 2007 | Substantially Equivalent | EXACTECH, INC. |
| K062250 | DELTA XTEND REVERSE SHOULDER SYSTEM | Feb 02, 2007 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K062116 | DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS | Aug 18, 2006 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K061439 | AEQUALIS REVERSED PROSTHESIS | Jul 20, 2006 | Substantially Equivalent | TORNIER |
| K060704 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM | May 19, 2006 | Substantially Equivalent | ZIMMER, INC. |
| K053274 | ANATOMICAL SHOULDER INVERSE/REVERSE | Jan 25, 2006 | Substantially Equivalent | ZIMMER GMBH |
| K052906 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | Dec 19, 2005 | Substantially Equivalent | ZIMMER, INC. |
| K052086 | ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER | Aug 31, 2005 | Substantially Equivalent | ENCORE MEDICAL, INC. |
| K051075 | ENCORE REVERSE SHOULDER PROSTHESIS | May 27, 2005 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K050315 | DELTA HUMERAL CUPS | May 16, 2005 | Substantially Equivalent | DEPUY ORTHOPAEDICS, INC. |
| K041066 | ENCORE REVERSE SHOULDER PROSTHESIS | Mar 24, 2005 | Substantially Equivalent | ENCORE MEDICAL, L.P. |
| K050316 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Mar 16, 2005 | Substantially Equivalent | TORNIER |
| K041873 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Aug 25, 2004 | Substantially Equivalent | TORNIER |
| K030941 | AEQUALIS REVERSED SHOULDER PROSTHESIS | May 14, 2004 | Substantially Equivalent | TORNIER |
| K021478 | DELTA SHOULDER | Nov 18, 2003 | Substantially Equivalent | DEPUY, INC. |
FEI Numbers
This FDA classification entry is associated with 194 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 194 registration numbers. Click on an entry to view related FDA registrations.