510(k) Report

Devices descending from K163669

20 later devices reach Humeris Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+1K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+1K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+1K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+1K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+1K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+1K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+1K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+2K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+2K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+2K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—