510(k) Report

Devices descending from K033516

135 later devices reach Depuy Global Cap HA Resurfacing Shoulder Humeral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+1K062661Aequalis Resurfacing HeadTornier200616—
+1K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc.2006121—
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+2K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+3K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K113413Ascend Shoulder SystemTornier, Inc.2012105—
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K120794Ascend Shoulder SystemTornier, Inc.201298—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+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—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+5K121493Ascend Shoulder SystemTornier, Inc.201297—
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+6K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+6K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+7K250644MSS - Monobloc stemMedacta International S.A.202611
+7K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243248Inhance Intact™Depuy Ireland UC20240—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+7K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+7K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+7K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+7K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+7K163669Humeris ShoulderFx Solutions201720—
+7K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+7K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+7K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+7K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+8K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+8K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+8K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+8K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+8K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+8K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+8K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+8K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+8K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+8K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+8K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+8K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+8K201315PERFORM Humeral System – StemTornier, Inc.2020111
+8K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+8K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+8K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—