510(k) Report

Devices descending from K921308

472 later devices reach HG Multilock Hip Prosthesis W/ TI-Nidium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19983091
+1K972893Partnership Revision Femoral StemsHowmedica Corp.1997153—
+1K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc.1997363—
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+2K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+2K051491Trabecular Metal Primary Hip ProsthesisZimmer, Inc.200525
+2K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.2003843
+2K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc.20032962
+2K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200210137
+2K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+2K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.200069—
+2K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000213—
+2K984492Tigran Hip ProsthesisPonmed, Ltd.19990—
+2K983404Type 3 Femoral ComponentsHowmedica Corp.19981021
+2K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc.19980—
+2K980813Reliance Long Stem Femoral ComponentsHowmedica, Inc.19980—
+2K980239Partnership Calcar Femoral ComponentsHowmedica, Inc.19980—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20218—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K193233Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)20200—
+3K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+3K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+3K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20160—
+3K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+3K120578Accolade II Hip StemHowmedica Osteonics2012461
+3K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+3K103479Novel Tapered Hip StemStryker Corp.201153—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+3K083312Minihip StemCorin USA201015—
+3K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+3K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+3K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.200754
+3K061461Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05Zimmer, Inc.20065—
+3K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+3K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.200411—
+3K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+3K040383Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc.20042—
+3K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003207—
+3K022549Restoration Modular SystemHowmedica Osteonics Corp.2002543
+3K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+4K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K251166Mfinity Femoral SystemMedacta International S.A.20250—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K251052Trivicta® Hip StemOrtho Development Corp.20250—
+4K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+4K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K201348DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd.20221—
+4K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+4K211703Insignia Hip StemStryker Orthopaedics20217—
+4K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+4K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+4K201673SMS Cementless StemMedacta International S.A.20203—
+4K192919Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.20196—
+4K192236Fitmore Hip StemZimmer GmbH20191—
+4K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191—
+4K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+4K170072Fitmore® Hip StemZimmer GmbH20170—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+4K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+4K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+4K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+4K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+4K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+4K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—