510(k) Report

Devices descending from K000575

307 later devices reach Global Advantage Extended Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134—
+1K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+1K082715Depuy Global AP Cta Humeral HeadDePuy Orthopaedics, Inc.20082—
+1K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+1K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+1K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+1K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+1K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.200561
+2K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+2K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+2K131112Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A.20130—
+2K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+2K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+2K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+2K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+2K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+2K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+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—
+3K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+3K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K103251Duocentric ReversedAston Medical20117—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+3K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+3K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—