510(k) Report

Devices descending from K905739

92 later devices reach Zimmer Ceramic Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030724Alumina Ceramic Femoral Heads, 28 and 32 MMZimmer, Inc.2003917
+2K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+3K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+3K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K083312Minihip StemCorin USA201015—
+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—
+5K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K131986Corin Minihip StemCorin USA20133—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K103518Trinity Acetabular SystemCorin USA20118—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+7K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+8K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+8K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+8K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+8K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K171249Entrada™ hip stemOrtho Development Corporation20172—
+8K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+9K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+9K251166Mfinity Femoral SystemMedacta International S.A.20250—
+9K251052Trivicta® Hip StemOrtho Development Corp.20250—
+9K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+9K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+9K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+9K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+9K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+9K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K211703Insignia Hip StemStryker Orthopaedics20217—
+9K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+9K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+9K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+9K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+10K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+10K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+10K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+10K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+10K210678implaFit® hip stemsImplantcast GmbH20223—
+10K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+10K221104Actera™ hip systemConformis, Inc.202211
+11K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+11K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+11K252401implaFit® short stemsImplantcast GmbH20260—
+11K252067Velora Acetabular SystemRestor3D, Inc.20250—
+11K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+11K232371Actinia® hip stemsImplantcast GmbH20231—
+11K231178ACTERA™ hip systemConformis, Inc.20230—
+12K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+12K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+12K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—