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
+1K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+1K133834Depuy Global Unite Shoulder SystemDepuy (Ireland)2014211
+1K111097Humelock Cemented Shoulder ProsthesisFx Solutions2011342
+1K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+1K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+1K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+1K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+1K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC200619413
+1K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc.2006200—
+1K042664LPS Upper ExtremityDepuy, Inc.20040—
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+1K021478Delta ShoulderDepuy, Inc.2003338—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+2K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+2K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+2K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+2K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+2K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+2K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+2K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+2K111902Aequalis Shoulder SystemTornier201149—
+2K103251Duocentric ReversedAston Medical20117—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+2K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+2K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.201071—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+2K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+2K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+2K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+2K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+2K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+2K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+2K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+2K063081Aequalis Shoulder SystemTornier2006162—
+2K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+2K061439Aequalis Reversed ProsthesisTornier2006199—
+2K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+2K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+2K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+2K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+2K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+2K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+2K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+2K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K241470CORE Shoulder SystemLinkBio Corp.202501
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+3K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+3K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—