510(k) Report

Devices descending from K850055

386 later devices reach Profile Femoral Hip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984459Depuy Profile Femoral Hip with PorocoatDePuy Orthopaedics, Inc.19990—
+1K961378Delta Hip ProsthesisZimmer, Inc.19963844
+2K992667ZMR Hip System-Revision TaperZimmer, Inc.19991141
+2K964769Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc.1997363—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+3K151739Revision Femoral StemLima Corporate S.P.A.20157—
+3K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+3K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+3K051491Trabecular Metal Primary Hip ProsthesisZimmer, Inc.200525
+3K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+3K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.2003843
+3K031572ZMR Hip System-XL, Models 9921, 9922 and 9923Zimmer, Inc.2003286
+3K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc.20032962
+3K994286ZMR Hip System-Porous RevisionZimmer, Inc.200010511
+3K984492Tigran Hip ProsthesisPonmed, Ltd.19990—
+3K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc.19980—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+4K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K161226Revision Femoral StemLima Corporate S.P.A.20170—
+4K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+4K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20160—
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+4K083312Minihip StemCorin USA201015—
+4K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+4K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+4K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+4K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.200754
+4K061461Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05Zimmer, Inc.20065—
+4K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+4K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.200411—
+4K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+5K212327M-Vizion MonoblocMedacta International S.A.20221—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+5K201673SMS Cementless StemMedacta International S.A.20203—
+5K192236Fitmore Hip StemZimmer GmbH20191—
+5K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+5K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191—
+5K181693SMS Femoral StemMedacta International S.A.20184—
+5K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+5K170072Fitmore® Hip StemZimmer GmbH20170—
+5K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+5K131986Corin Minihip StemCorin USA20133—
+5K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+5K123392Avenir Muller StemZimmer GmbH2013414
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH201101
+5K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+5K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+5K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+5K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+5K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+5K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+5K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+5K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083—
+5K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+5K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc.20073Class I
+5K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+5K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+5K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+5K042344Excia Total Hip SystemAesculap, Inc.200519810
+5K043079Bicontact Hip System with U-CapAesculap2004166—
+6K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—