510(k) Report

Devices descending from K111635

4 later devices reach Smith & Nephew RJ Constrained Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241461Mpact Constrained LinerMedacta International S.A.20251—
+1K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+1K122139Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc.20121—
+2K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—