510(k) Report

Devices descending from K211004

4 later devices reach GMK Spherika Femurs and Fixed Tibial Trays Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262057GMK ExtensionMedacta International SA20260—
+1K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+1K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+2K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—