510(k) Report

Devices descending from K032507

123 later devices reach Interlok Bio-Modular Humeral Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+1K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+2K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+2K113413Ascend Shoulder SystemTornier, Inc.2012105—
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K120794Ascend Shoulder SystemTornier, Inc.201298—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+6K250644MSS - Monobloc stemMedacta International S.A.202611
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K163669Humeris ShoulderFx Solutions201720—
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K141345Aequalis FX2Tornier S.A.S.201411
+6K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+7K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+7K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+7K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+7K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+7K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+7K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+7K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+7K201315PERFORM Humeral System – StemTornier, Inc.2020111
+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
+7K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+7K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+7K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+7K152966Aequalis Fx2Tornier S.A.S.201601
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+8K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—