510(k) Report

Devices descending from K073676

161 later devices reach Depuy Delta Xtend Reverse Shoulder High Mobility Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+1K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+1K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+2K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+2K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K103251Duocentric ReversedAston Medical20117—
+2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+2K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163669Humeris ShoulderFx Solutions201720—
+4K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+4K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—