510(k) Report

Devices descending from K914695

451 later devices reach Global Total Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+3K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+3K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+3K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+3K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+3K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC200619413
+3K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+3K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc.2006200—
+3K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+3K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+3K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050761Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMZimmer, Inc.200506
+3K042664LPS Upper ExtremityDepuy, Inc.20040—
+3K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+3K021478Delta ShoulderDepuy, Inc.2003338—
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K213856Identity Shoulder SystemZimmer, Inc.20224—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+4K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+4K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+4K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+4K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+4K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—