510(k) Report

Devices descending from K213117

4 later devices reach FX V135 Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+1K250644MSS - Monobloc stemMedacta International S.A.202611
+1K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+2K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—