510(k) Report

Devices descending from K053274

239 later devices reach Anatomical Shoulder Inverse/Reverse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+3K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+3K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+3K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+3K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+3K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+3K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+3K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+3K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+3K170452Medacta Shoulder SystemMedacta International S.A.201712—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+4K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+4K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+4K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+4K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—