510(k) Report

Devices descending from K081059

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+1K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+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—
+1K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+2K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+2K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+2K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+2K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+2K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+2K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+2K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+2K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+2K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+2K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+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—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+2K162455Humelock Reversed ShoulderFx Solutions201717—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+2K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+2K103251Duocentric ReversedAston Medical20117—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+3K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+3K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+3K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+3K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—