510(k) Report

Devices descending from K100142

147 later devices reach Aequalis Reversed Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162455Humelock Reversed ShoulderFx Solutions201717—
+1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+1K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+1K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+1K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+1K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+1K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+1K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+1K103251Duocentric ReversedAston Medical20117—
+1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+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—
+2K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+2K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+2K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+2K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+2K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+2K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+2K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+2K141345Aequalis FX2Tornier S.A.S.201411
+2K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+2K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K240876Identity Shoulder SystemZimmer, Inc.20241—
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+3K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+3K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+3K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K152966Aequalis Fx2Tornier S.A.S.201601
+3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+4K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163669Humeris ShoulderFx Solutions201720—
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—