510(k) Report

Devices descending from K061066

16 later devices reach Synergy Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+1K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—