510(k) Report

Devices descending from K150829

3 later devices reach U2 Total Knee System- Additional Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+1K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+1K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—