510(k) Report

Devices descending from K043100

176 later devices reach Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+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—
+6K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+6K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+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—
+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—
+7K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+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—
+7K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+7K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+7K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+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
+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—
+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
+8K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+8K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+8K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+8K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+8K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+8K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+9K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+9K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+9K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+9K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—