510(k) Report

Devices descending from K091751

159 later devices reach Depuy Delta Xtend Reverse Shoulder XLK Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K163669Humeris ShoulderFx Solutions201720—
+5K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K250644MSS - Monobloc stemMedacta International S.A.202611
+6K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K254003JARVIS Metaphyseal StemFH Industrie20260—
+7K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+7K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243248Inhance Intact™Depuy Ireland UC20240—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+7K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—