510(k) Report

Devices descending from K181635

2 later devices reach GMK Sphere CR Tibial Inserts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+2K262057GMK ExtensionMedacta International SA20260—