510(k) Report

Devices descending from K082120

164 later devices reach Aequalis Reversed Fracture Shoulder Prothesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162455Humelock Reversed ShoulderFx Solutions201717—
+1K141345Aequalis FX2Tornier S.A.S.201411
+1K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+1K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+1K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+1K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+1K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+1K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+2K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+2K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+2K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+2K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+2K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+2K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+2K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+2K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+2K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+2K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+2K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+2K152966Aequalis Fx2Tornier S.A.S.201601
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+2K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+2K141006RSP Humeral Socket InsertDjo Global2014212
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+2K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+2K103251Duocentric ReversedAston Medical20117—
+2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K240876Identity Shoulder SystemZimmer, Inc.20241—
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+3K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+3K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—