510(k) Report

Devices descending from K062250

250 later devices reach Delta Xtend Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+1K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+1K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+1K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+1K170452Medacta Shoulder SystemMedacta International S.A.201712—
+1K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+1K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+1K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+1K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+1K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+1K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+1K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+1K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+1K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+1K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+2K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+2K241470CORE Shoulder SystemLinkBio Corp.202501
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+2K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+2K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+2K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K162455Humelock Reversed ShoulderFx Solutions201717—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+2K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+2K141345Aequalis FX2Tornier S.A.S.201411
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+2K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K131129Cas Psi ShoulderZimmer Cas201339—
+2K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K103251Duocentric ReversedAston Medical20117—
+2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+2K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+2K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+2K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+3K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+3K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+3K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+3K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+3K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+3K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+3K152966Aequalis Fx2Tornier S.A.S.201601
+3K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+3K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—