510(k) Report

Devices descending from K060704

207 later devices reach Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K152966Aequalis Fx2Tornier S.A.S.201601
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+6K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+6K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K163669Humeris ShoulderFx Solutions201720—
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+7K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+7K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+7K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+7K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+7K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—