510(k) Report

Devices descending from K073676

161 later devices reach Depuy Delta Xtend Reverse Shoulder High Mobility Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+5K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+5K152966Aequalis Fx2Tornier S.A.S.201601
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+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—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+6K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+6K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+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
+7K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+7K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+7K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+8K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—