510(k) Report

Devices descending from K080642

172 later devices reach Comprehensive Reverse Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163669Humeris ShoulderFx Solutions201720—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+4K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+5K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+5K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+5K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+5K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+7K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+7K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+7K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—