510(k) Report

Devices descending from K992065

405 later devices reach Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+4K192967Medacta Shoulder SystemMedacta International S.A.20200—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+4K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+4K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+4K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+4K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+4K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+4K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+4K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+4K113413Ascend Shoulder SystemTornier, Inc.2012105—
+4K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+5K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+5K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+5K243509Archer PSI System3D-Side20250—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223