510(k) Report

Devices descending from K111546

13 later devices reach U2 Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+1K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+1K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+1K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+1K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+1K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+2K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—