510(k) Report

Devices descending from K103733

8 later devices reach United U2 Xpe Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+1K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+1K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+1K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+1K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+1K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+2K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+2K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—