510(k) Report

Devices descending from K914695

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+5K143552Simpliciti Shoulder SystemTornier, Inc.201524—
+5K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+5K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+5K141345Aequalis FX2Tornier S.A.S.201411
+5K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+5K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+5K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+5K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+5K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+5K131129Cas Psi ShoulderZimmer Cas201339—
+5K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+5K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+5K122442Depuy Cta Reverse Shoulder SystemDepuy France20121—
+5K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+5K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+5K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+5K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+5K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+5K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+5K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+5K071948Aequalis Reversed AdapterTornier2007178—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+6K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+6K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+6K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+6K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+6K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+6K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+6K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+6K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+6K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+6K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+6K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+6K150730Zimmer PSI Shoulder SystemZimmer201511—
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K141006RSP Humeral Socket InsertDjo Global2014212
+6K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+6K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+6K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+6K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+7K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K243509Archer PSI System3D-Side20250—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+7K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+7K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+7K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+7K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+7K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+7K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+7K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+7K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+7K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+7K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—