510(k) Report

Devices descending from K022902

285 later devices reach Smith & Nephew Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+1K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+1K042344Excia Total Hip SystemAesculap, Inc.200519810
+1K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+2K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+2K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+2K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+2K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+2K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+2K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+2K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+2K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+2K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+2K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+2K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+2K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+2K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+2K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+2K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+2K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+2K043079Bicontact Hip System with U-CapAesculap2004166—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+3K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+3K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+3K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+3K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+3K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+3K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+3K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K093472Trinity Acetabular SystemCorin USA20101171
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K083312Minihip StemCorin USA201015—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+3K081023Evolis Total Knee SystemMedacta International S.A.2008781
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K142069GMK ExtensionMedacta International20144—
+4K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K131986Corin Minihip StemCorin USA20133—
+4K131647Trinity Acetabular SystemCorin USA201322—
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+4K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+4K130128Trinity Acetabular SystemCorin Medical201317—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—