510(k) Report

Devices descending from K013475

216 later devices reach Trident Porous Titanium Acetabular Component with Peri-Apatite Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042344Excia Total Hip SystemAesculap, Inc.200519810
+1K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+2K163577Ecofit® Hip SystemImplantcast GmbH201791
+2K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+2K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+2K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+2K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+2K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+2K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+2K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+2K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+2K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+2K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+2K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+2K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+3K252451EPORE® XO cup systemImplantcast GmbH20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+3K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+3K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+3K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+3K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+3K203420EcoFit® Hip SystemImplantcast GmbH20214—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+3K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+3K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+3K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+3K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+3K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+3K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+3K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K083312Minihip StemCorin USA201015—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+3K081023Evolis Total Knee SystemMedacta International S.A.2008781
+3K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.20200—
+4K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K142069GMK ExtensionMedacta International20144—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K131986Corin Minihip StemCorin USA20133—
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+5K262057GMK ExtensionMedacta International SA20260—