510(k) Report

Devices descending from K060874

200 later devices reach Depuy Global AP Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+1K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+1K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+1K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+1K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+1K063081Aequalis Shoulder SystemTornier2006162—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K241470CORE Shoulder SystemLinkBio Corp.202501
+2K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+2K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+2K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+2K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+2K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+2K163669Humeris ShoulderFx Solutions201720—
+2K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+2K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+2K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+2K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+2K131129Cas Psi ShoulderZimmer Cas201339—
+2K111902Aequalis Shoulder SystemTornier201149—
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+3K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+3K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+3K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+3K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K113413Ascend Shoulder SystemTornier, Inc.2012105—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+4K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+4K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K120794Ascend Shoulder SystemTornier, Inc.201298—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K243509Archer PSI System3D-Side20250—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—