510(k) Report

Devices descending from K100981

3 later devices reach United Stem, Psa Type through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190100USTAR II SystemUnited Orthopedic Corporation201925
+2K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+2K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—