510(k) Report

Devices descending from K990369

23 later devices reach Synergy Cemented Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K153216Alpine Cemented Hip SystemOrtho Development Corporation20160—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+1K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+1K042252Nexflex Total Hip SystemAlphatec/Nexmed20040—
+1K031165Plus Orthopedics Cemented Hip StemPlus Orthopedics20031—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+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—
+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—