510(k) Report

Devices descending from K980711

309 later devices reach Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc.20032962
+1K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+1K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000213—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+2K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+2K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+2K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+2K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+2K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+2K083312Minihip StemCorin USA201015—
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+2K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+2K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+2K061461Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05Zimmer, Inc.20065—
+2K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+2K040383Triflange II Acetabular Cup SystemDePuy Orthopaedics, Inc.20042—
+2K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003207—
+3K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K251166Mfinity Femoral SystemMedacta International S.A.20250—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K251052Trivicta® Hip StemOrtho Development Corp.20250—
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+3K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+3K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+3K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC20230—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K201348DePuy 3D Additive TriFlange Acetabular CupDepuy International, Ltd.20221—
+3K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+3K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+3K192919Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.20196—
+3K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+3K131986Corin Minihip StemCorin USA20133—
+3K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+3K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.201291
+3K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+3K103518Trinity Acetabular SystemCorin USA20118—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+3K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+3K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+3K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+3K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+3K042344Excia Total Hip SystemAesculap, Inc.200519810
+3K043079Bicontact Hip System with U-CapAesculap2004166—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+4K162775Legion Cone SystemSmith & Nephew, Inc.201752
+4K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+4K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+4K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—