510(k) Report

Devices descending from K103497

9 later devices reach Ceramic Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+1K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—