FDA 510(k) Applications for Medical Device Product Code "PHX"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K212415 | Arthrex Inc. | Arthrex Modular Glenoid System-Titanium Glenosphere | 11/17/2021 |
| K170414 | Arthrex Inc. | Arthrex Univers Revers Apex Humeral Stems | 12/14/2017 |
| K173900 | Arthrex Inc. | Arthrex Univers Revers Modular Glenoid System | 04/20/2018 |
| K191960 | Arthrex Inc. | Arthrex Univers Revers Modular Glenoid System | 12/23/2019 |
| K230366 | Arthrex Inc. | Arthrex Univers Revers Monoblock Stem Size 4/33 | 04/10/2023 |
| K182039 | Arthrex Inc. | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | 09/28/2018 |
| K193372 | Arthrex Inc. | Univers Revers Modular Glenoid System (Augemented baseplates) | 01/10/2020 |
| K200895 | Arthrex Inc. | Univers Revers Modular Glenoid System, Half Augment Baseplate | 08/13/2020 |
| K211074 | Arthrex Inc. | Univers Revers Modular Glenoid System, Standard Augment Baseplates | 09/02/2021 |
| K172371 | Arthrex, Inc. | Arthrex UNIVERS REVERS COATED BASEPLATE | 03/22/2018 |
| K142863 | Arthrex, Inc. | Univers Rivers Shoulder Prosthesis System | 11/25/2014 |
| K203375 | Arthrosurface Inc. | OVOMotion Reverse Shoulder Arthroplasty System | 06/24/2021 |
| K103251 | ASTON MEDICAL | DUOCENTRIC REVERSED | 10/28/2011 |
| K121183 | BIOMET CORPORATION | COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS | 07/26/2012 |
| K193373 | Biomet Inc. | Comprehensive« Reverse Shoulder | 04/15/2020 |
| K172502 | Biomet Manufacturing Corp | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | 01/03/2018 |
| K181611 | Biomet Manufacturing Corp | Comprehensive Reverse Shoulder System | 09/24/2018 |
| K093803 | BIOMET MANUFACTURING CORP. | BIO-MODULAR REVERSE SHOLDER | 10/19/2010 |
| K131353 | BIOMET MANUFACTURING CORP. | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE | 10/08/2013 |
| K113069 | BIOMET MANUFACTURING CORP. | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY | 01/11/2012 |
| K132239 | BIOMET MANUFACTURING CORP. | COMPREHENSIVE REVERSE SHOULDER SCREWS | 09/06/2013 |
| K072804 | BIOMET MANUFACTURING CORP. | COMPREHENSIVE RS SHOULDER SYSTEM | 12/12/2007 |
| K173411 | Biomet Manufacturing Corp. | Comprehensive Segmental Revision System (SRS) | 02/08/2018 |
| K202232 | Biomet Manufacturing Corp. | Comprehensive Vault Reconstruction System | 02/19/2021 |
| K152754 | BIOMET MANUFACTURING CORP. | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) | 05/16/2016 |
| K211729 | Biomet Manufacturing Corp. | Comprehensive« Convertible Glenoid - Vivacit-E Liner | 11/04/2021 |
| K214001 | Biomet Manufacturing Corp. | Comprehensive« Shoulder System, Comprehensive« Reverse Shoulder System | 03/15/2023 |
| K140652 | BIOMET MANUFACTURING CORP. | POROUS COATED COMPREHENSIVE FRACTURE STEMS | 07/03/2014 |
| K130390 | BIOMET MANUFACTURING, INC. | COMPREHENSIVE CONVERTIBLE GLENOID | 10/09/2013 |
| K113121 | BIOMET MANUFACTURING, INC. | COMPREHENSIVE REVERSE SHOULDER | 12/16/2011 |
| K080642 | BIOMET, INC. | COMPREHENSIVE REVERSE SHOULDER | 07/09/2008 |
| K120121 | BIOMET, INC. | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE | 02/16/2012 |
| K213349 | Catalyst OrthoScience, Inc | Catalyst R1 Reverse Shoulder System | 06/23/2022 |
| K202611 | Catalyst OrthoScience, Inc. | Catalyst OrthoScience R1 Reverse Shoulder System | 02/12/2021 |
| K232583 | Catalyst OrthoScience, Inc. | Catalyst R1 Reverse Shoulder System | 09/20/2023 |
| K211991 | Catalyst OrthoScience, Inc. | Catalyst R1 Reverse Shoulder System | 07/28/2021 |
| K223655 | Catalyst OrthoScience, Inc. | Catalyst R1 Reverse Shoulder System | 05/09/2023 |
| K183077 | DePuy (Ireland) | Delta Xtend Reverse Shoulder System | 05/17/2019 |
| K192855 | DePuy (Ireland) | DELTA XTEND(TM) Reverse Shoulder System | 02/24/2020 |
| K101996 | DEPUY (IRELAND) | DEPUY GLOBAL UNITE SHOULDER SYSTEM | 12/15/2010 |
| K120174 | DEPUY FRANCE | DEPUT DELTA XTEND REVERSE SHOULDER | 06/11/2012 |
| K122442 | DEPUY FRANCE | DEPUY CTA REVERSE SHOULDER SYSTEM | 09/06/2012 |
| K203694 | DePuy Ireland UC | DELTA XTEND Reverse Shoulder System | 07/22/2021 |
| K170748 | DePuy Ireland UC | GLOBAL UNITE Platform Shoulder System | 01/11/2018 |
| K212710 | DePuy Ireland UC | GLOBAL UNITEÖ Platform Shoulder System | 09/15/2021 |
| K202098 | DePuy Ireland UC | GLOBAL UNITEÖ Platform Shoulder System | 11/25/2020 |
| K212737 | Depuy Ireland UC | INHANCEÖ Reverse Shoulder System | 04/21/2022 |
| K221467 | Depuy Ireland UC | INHANCETM Reverse Glenoid Peripheral Posts | 08/31/2022 |
| K223211 | Depuy Ireland UC | INHANCETM Shoulder System û Humeral Stems and Stemless | 12/02/2022 |
| K210167 | DePuy Orthopaedics Inc. | DELTA XTEND Reverse Shoulder System | 02/19/2021 |
| K062116 | DEPUY ORTHOPAEDICS, INC. | DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS | 08/18/2006 |
| K050315 | DEPUY ORTHOPAEDICS, INC. | DELTA HUMERAL CUPS | 05/16/2005 |
| K071379 | DEPUY ORTHOPAEDICS, INC. | DELTA XTEND REVERSE SHOULDER MODULAR STEM | 09/11/2007 |
| K062250 | DEPUY ORTHOPAEDICS, INC. | DELTA XTEND REVERSE SHOULDER SYSTEM | 02/02/2007 |
| K073676 | DEPUY ORTHOPAEDICS, INC. | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP | 01/29/2008 |
| K021478 | DEPUY, INC. | DELTA SHOULDER | 11/18/2003 |
| K192448 | DePuy(Ireland) | Delta Xtend Revers Shoulder System | 10/04/2019 |
| K141006 | DJO GLOBAL | RSP HUMERAL SOCKET INSERT | 06/05/2014 |
| K092873 | DJO SURGICAL | REVERSE SHOULDER PROSTHESIS | 10/27/2009 |
| K052086 | ENCORE MEDICAL, INC. | ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER | 08/31/2005 |
| K173073 | Encore Medical, L.P. | AltiVate Anatomic to Reverse Conversion Module | 12/26/2017 |
| K141990 | ENCORE MEDICAL, L.P. | ENCORE HUMERAL SHOULDER STEM | 11/07/2014 |
| K041066 | ENCORE MEDICAL, L.P. | ENCORE REVERSE SHOULDER PROSTHESIS | 03/24/2005 |
| K051075 | ENCORE MEDICAL, L.P. | ENCORE REVERSE SHOULDER PROSTHESIS | 05/27/2005 |
| K111061 | ENCORE MEDICAL, L.P. | REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) | 07/20/2011 |
| K111735 | ENCORE MEDICAL, L.P. | REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER | 10/03/2011 |
| K103208 | ENCORE MEDICAL, L.P. | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM | 01/31/2011 |
| K100741 | ENCORE MEDICAL, L.P. | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 | 08/02/2010 |
| K112069 | ENCORE MEDICAL, L.P. | RSP GLENOID BASEPLATE POROUS COATED | 11/15/2011 |
| K130550 | ENCORE MEDICAL, L.P. | RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW | 03/24/2014 |
| K140904 | ENCORE MEDICAL, L.P. | RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 | 05/06/2014 |
| K111629 | ENCORE MEDICAL, L.P. | TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 | 09/16/2011 |
| K162325 | Exactech Inc | Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw | 03/06/2017 |
| K162726 | EXACTECH INC | Exactech« Equinoxe« Preserve Stem | 02/01/2017 |
| K180632 | Exactech Inc. | Exactech Equinoxe Small Reverse Shoulder System | 07/25/2018 |
| K191561 | Exactech, Inc | Exactech Equinoxe Humeral Augmented Trays | 08/20/2019 |
| K223833 | Exactech, Inc | Exactech« Equinoxe« Reverse Humeral Liners and Humeral Adapter Trays | 09/14/2023 |
| K193098 | Exactech, Inc | Exactech« Equinoxe« Reverse Shoulder Glenospheres | 02/20/2020 |
| K110708 | EXACTECH, INC. | EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... | 04/01/2011 |
| K063569 | EXACTECH, INC. | EQUINOXE REVERSE SHOULDER SYSTEM | 02/23/2007 |
| K073688 | EXACTECH, INC. | EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW | 02/29/2008 |
| K102951 | EXACTECH, INC. | EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) | 11/04/2010 |
| K131575 | EXACTECH, INC. | EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT | 07/03/2013 |
| K092900 | EXACTECH, INC. | EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM | 01/07/2010 |
| K150458 | EXACTECH, INC. | Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere | 05/14/2015 |
| K093275 | EXACTECH, INC. | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER | 05/27/2010 |
| K082702 | EXACTECH, INC. | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY | 10/10/2008 |
| K121067 | EXACTECH, INC. | EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE | 12/06/2012 |
| K182536 | Exactech, Inc. | 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 | 10/12/2018 |
| K101909 | EXACTECH, INC. | EXACTECH EQUINOXE, PLATFORM FRACTURE STEM | 08/02/2010 |
| K232226 | FH Industrie | ARROW Off-Centred Humeral Insert | 08/29/2023 |
| K202024 | FH Industrie | ARROW Short Stem Humeral System | 11/30/2021 |
| K150568 | FOURNITURES HOSPITALIERES INDUSTRIE | ARROW Humeral stems size 6 and 16 | 10/29/2015 |
| K171789 | Fournitures Hospitalieres Industrie | ARROW Reverse Porous Glenoid | 01/23/2018 |
| K142778 | Fournitures Hospitalieres Industrie | ARROW Reverse Shoulder long keel and short keel glenoid base | 03/20/2015 |
| K112193 | FOURNITURES HOSPITALIERES INDUSTRIE | ARROW REVERSE SHOULDER SYSTEM | 07/12/2012 |
| K223801 | FX Shoulder USA, Inc | FX V135(TM) Shoulder Prosthesis | 06/05/2023 |
| K192206 | FX Shoulder USA, Inc. | 32mm Glenosphere and Humeral Cup | 10/08/2019 |
| K213117 | FX Shoulder USA, Inc. | FX V135 Shoulder Prosthesis | 06/07/2022 |
| K192799 | FX Shoulder USA, Inc. | Glenoid Baseplate with Screw | 02/21/2020 |
| K191146 | FX Shoulder USA, Inc. | Humelock TiN Coated Glenosphere | 07/15/2020 |
| K193394 | FX Shoulder USA, Inc. | Humeral Cup Stability & Humeral Cup 135/145o Stability | 04/29/2020 |
| K222936 | FX Shoulder USA, Inc. | Humeris« 135 Shoulder System | 11/07/2022 |
| K210790 | FX Shoulder USA, Inc. | Lateralized and Augmented Baseplates | 08/25/2021 |
| K150488 | FX SOLUTIONS | Humelock II Reversible Shoulder System | 11/13/2015 |
| K162455 | FX SOLUTIONS | Humelock Reversed Shoulder | 01/17/2017 |
| K163669 | Fx Solutions | Humeris Shoulder | 05/17/2017 |
| K130895 | HOWMEDICA OSTEONICS CORP | REUNION RSA SHOULDER SYSTEM | 12/27/2013 |
| K120374 | INGEN ORTHOPEDICS LLC | SEVIIN REVERSE SHOULDER | 07/09/2012 |
| K190588 | Integra LifeSciences Corporation | Integra TITAN Reverse Shoulder System | 12/02/2019 |
| K181999 | Integra Lifesciences Corporation | Integra TITAN Reverse Shoulder System | 10/12/2018 |
| K173717 | Integra LifeSciences Corporation | Integra TITAN Reverse Shoulder System | 06/21/2018 |
| K161189 | INTEGRA LIFESCIENCES CORPORATION | Integra TITAN Reverse Shoulder System | 08/25/2016 |
| K191746 | Limacorporate S.p.A | SMR TT Augmented Glenoid System | 11/22/2019 |
| K200171 | LimaCorporate S.p.A | SMR TT Augmented Glenoid System | 11/19/2020 |
| K210717 | LimaCorporate S.p.A. | Bone Screws dia. 5,0 mm | 07/12/2021 |
| K113523 | LIMACORPORATE S.P.A. | LIMACORPORATE SMR REVERSE SHOULDER SYSTEM | 12/20/2011 |
| K212800 | LimaCorporate S.p.A. | PRIMA Humeral System and SMR Glenosphere ╪42 | 02/25/2022 |
| K142139 | LIMACORPORATE S.P.A. | SMR 40MM GLENOSPHERE | 11/07/2014 |
| K113254 | LIMACORPORATE S.P.A. | SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS | 02/24/2012 |
| K110598 | LIMACORPORATE S.P.A. | SMR REVERSE SHOULDER SYSTEM | 08/18/2011 |
| K161120 | LIMACORPORATE S.P.A. | SMR TT Metal Back Glenoid, Bone Graft instruments | 02/21/2017 |
| K193175 | Medacta Inernational SA | Lateralized Glenosphere | 08/11/2020 |
| K213459 | Medacta International S.A. | Glenoid Reconstruction System | 11/23/2022 |
| K181826 | Medacta International SA | Glenoid Polyaxial Non-locking Screws | 12/10/2018 |
| K210207 | Medacta International SA | Humeral Eccentric Reverse Metaphysis | 03/26/2021 |
| K170452 | Medacta International SA | Medacta Shoulder System | 10/05/2017 |
| K180089 | Medacta International SA | Medacta Shoulder System Short Humeral Diaphysis | 04/05/2018 |
| K171058 | Medacta International SA | Medacta Shoulder System: Threaded Glenoid Baseplate | 12/13/2017 |
| K190738 | Medacta International SA | MyShoulder Placement Guides | 12/13/2019 |
| K203755 | Medacta International SA | Shoulder System - TiNbN Coating | 03/02/2021 |
| K192967 | Medacta International, SA | Medacta Shoulder System | 03/25/2020 |
| K210533 | Shoulder Innovations, Inc. | Inset Reverse Total Shoulder System | 08/20/2021 |
| K081016 | SMITH & NEPHEW, INC. | SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM | 09/05/2008 |
| K211553 | Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc. | Tecomet Global Unite Short Stem Instrumentation | 08/04/2021 |
| K071948 | TORNIER | AEQUALIS REVERSED ADAPTER | 10/18/2007 |
| K061439 | TORNIER | AEQUALIS REVERSED PROSTHESIS | 07/20/2006 |
| K050316 | TORNIER | AEQUALIS REVERSED SHOULDER PROSTHESIS | 03/16/2005 |
| K081059 | TORNIER | AEQUALIS REVERSED SHOULDER PROSTHESIS | 07/17/2008 |
| K100142 | TORNIER | AEQUALIS REVERSED SHOULDER PROSTHESIS | 05/06/2010 |
| K030941 | TORNIER | AEQUALIS REVERSED SHOULDER PROSTHESIS | 05/14/2004 |
| K041873 | TORNIER | AEQUALIS REVERSED SHOULDER PROSTHESIS | 08/25/2004 |
| K112144 | TORNIER | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS | 03/13/2012 |
| K141345 | Tornier SAS | AEQUALIS FX2 | 11/18/2014 |
| K152966 | Tornier SAS | Aequalis Fx2 | 01/14/2016 |
| K140478 | Tornier SAS | AEQUALIS REVERSED SHOULDER PROSTHESIS | 08/06/2014 |
| K131231 | Tornier SAS | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | 10/16/2013 |
| K140082 | Tornier SAS | AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM | 07/18/2014 |
| K120739 | TORNIER, INC. | AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM | 07/05/2012 |
| K110599 | TORNIER, INC. | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM | 06/14/2011 |
| K112615 | TORNIER, INC. | AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM | 10/11/2011 |
| K183696 | Tornier, Inc. | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | 01/30/2019 |
| K161742 | Tornier, Inc. | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | 11/15/2016 |
| K213124 | Tornier, Inc. | Tomier PerformÖ Reversed Glenoid Cannulated Glenospheres | 10/26/2021 |
| K141029 | TORNIER, INC. | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM | 06/18/2014 |
| K220914 | Tornier, Inc. | Tornier Perform Humeral System û Fracture | 10/14/2022 |
| K211359 | Tornier, Inc. | Tornier PerformÖ Patient-Matched Primary Reversed Glenoid and BLUEPRINTÖ Patient Specific Instrumentation | 11/12/2021 |
| K132285 | TORNIER, SAS | AEQUALIS REVERSED SHOULDER PROSTHESIS | 12/05/2013 |
| K200368 | Waldemar Link GmbH & Co. KG | LINK Embrace Shoulder System - Reverse Configuration | 02/05/2021 |
| K212992 | Waldemar Link GmbH & Co. KG | LINK« Embrace Shoulder System - Reverse Configuration | 11/18/2021 |
| K053274 | ZIMMER GMBH | ANATOMICAL SHOULDER INVERSE/REVERSE | 01/25/2006 |
| K193099 | Zimmer GmbH | Anatomical Shoulder System | 01/29/2020 |
| K170711 | Zimmer GmbH | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | 06/01/2017 |
| K052906 | ZIMMER, INC. | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | 12/19/2005 |
| K130661 | ZIMMER, INC. | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | 05/09/2013 |
| K133378 | ZIMMER, INC. | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | 05/12/2014 |
| K172767 | Zimmer, Inc. | Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid | 11/30/2017 |
| K122692 | ZIMMER, INC. | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS | 12/03/2012 |
| K060704 | ZIMMER, INC. | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM | 05/19/2006 |
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