510(k) Report

Devices descending from K963509

44 later devices reach Global Taper Tapered Hip System, GT Spectron 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
+1K141370Renovis Cemented Hip SystemRenovis Surgical Technologies, Inc.20140—
+1K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K072817Echelon Titanium Hip SystemSmith & Nephew, Inc.20086—
+1K061066Synergy Hip SystemSmith & Nephew, Inc.200616—
+1K053246Patient Matched Hip StemSmith & Nephew, Inc.20061—
+1K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+1K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056—
+1K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+2K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+3K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—