510(k) Report

Devices descending from K082424

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation20250—
+1K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210—
+1K190100USTAR II SystemUnited Orthopedic Corporation201925
+1K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+1K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+1K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+1K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+1K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.201310—
+1K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+2K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+2K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+2K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+2K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+2K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—