510(k) Report

Devices descending from K063211

5 later devices reach Proven Knee System High Flexion Tibial Insert through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+1K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+1K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+1K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+2K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—