510(k) Report

Devices descending from K010657

136 later devices reach Copeland MB Resurfacing Humeral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+8K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+8K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+8K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+8K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+8K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+8K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+8K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+8K152966Aequalis Fx2Tornier S.A.S.201601
+9K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+9K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+9K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+9K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+9K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+9K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+9K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+9K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+9K240876Identity Shoulder SystemZimmer, Inc.20241—
+9K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+9K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+9K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+9K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+9K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+9K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+9K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+10K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+10K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+10K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+10K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+10K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+10K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+11K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+11K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+12K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+12K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+13K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—