510(k) Report

Devices descending from K011533

378 later devices reach Depuy Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+1K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2007141
+1K031803Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2003377—
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K222296ARTICUL/EZE Ceramic HeadsDepuy Ireland UC20236—
+2K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+2K073567Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH200871
+2K062748Modification: to Depuy Delta Ceramic Femoral HeadDePuy Orthopaedics, Inc.2006219—
+2K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+2K042091Biolox Delta Ceramic HeadsBiomet, Inc.20053452
+2K041940Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral HeadsHowmedica Osteonics Corp.200518—
+2K040644Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc.2004222—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+3K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+3K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+3K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+3K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+3K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+3K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+3K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+3K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+3K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+3K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+4K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+4K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+4K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+4K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+4K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+4K131518Mectacer Biolox Option HeadsMedacta International20130—
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+4K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+4K083312Minihip StemCorin USA201015—
+4K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+4K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+4K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+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—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—