510(k) Report

Devices descending from K130299

4 later devices reach GMK Hinge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+1K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+1K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+2K211664GMK Sphere RevisionMedacta International S.A.20210—