510(k) Report

Devices descending from K003044

146 later devices reach Copeland Resurfacing Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+9K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+9K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+9K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+9K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+9K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+9K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+9K201315PERFORM Humeral System – StemTornier, Inc.2020111
+9K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+9K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+9K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+9K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+9K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+9K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+9K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+9K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+9K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+9K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+9K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+9K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+9K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+10K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+10K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+10K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+10K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+10K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+10K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+10K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+10K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+10K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+10K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+10K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+10K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+10K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+10K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+10K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+11K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+11K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+11K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+11K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+11K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+12K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+12K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+13K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+13K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+14K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—