510(k) Report

Devices descending from K964650

311 later devices reach TCP-Coated Porocoat Aml Femoral Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984154Apf Porous Coated Line ExtensionBiomet, Inc.19990—
+1K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19983091
+2K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc.20032962
+2K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+2K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000213—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+3K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+3K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+3K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+3K083312Minihip StemCorin USA201015—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+3K061461Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05Zimmer, Inc.20065—
+3K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+3K040383Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc.20042—
+3K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003207—
+4K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+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—
+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—
+4K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC20230—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+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—
+4K192919Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.20196—
+4K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+4K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+4K131986Corin Minihip StemCorin USA20133—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.201291
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+4K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+4K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+4K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+4K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+4K042344Excia Total Hip SystemAesculap, Inc.200519810
+4K043079Bicontact Hip System with U-CapAesculap2004166—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+5K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+5K162775Legion Cone SystemSmith & Nephew, Inc.201752
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302