510(k) Report

Devices descending from K060988

194 later devices reach Total and Hemi Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111902Aequalis Shoulder SystemTornier201149—
+1K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+1K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+1K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.201071—
+1K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+1K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+2K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+2K143552Simpliciti Shoulder SystemTornier, Inc.201524—
+2K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+3K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+3K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+3K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K243509Archer PSI System3D-Side20250—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K163669Humeris ShoulderFx Solutions201720—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—