510(k) Report

Devices descending from K071948

178 later devices reach Aequalis Reversed Adapter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+1K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K162455Humelock Reversed ShoulderFx Solutions201717—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K141345Aequalis FX2Tornier S.A.S.201411
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+2K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+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—
+3K152966Aequalis Fx2Tornier S.A.S.201601
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K103251Duocentric ReversedAston Medical20117—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+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—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—