510(k) Report

Devices descending from K905786

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC200619413
+2K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+2K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+2K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K111902Aequalis Shoulder SystemTornier201149—
+2K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.201071—
+2K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+2K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K143552Simpliciti Shoulder SystemTornier, Inc.201524—
+3K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+3K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+4K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+4K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+4K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+4K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K243509Archer PSI System3D-Side20250—
+5K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K163669Humeris ShoulderFx Solutions201720—
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K162455Humelock Reversed ShoulderFx Solutions201717—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+6K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+6K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—