510(k) Report

Devices descending from K993601

299 later devices reach Howmedica Osteonics Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K110290Exeter Hip StemHowmedica Osteonics Corp.2011371
+1K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp.200229812
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+2K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+2K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp.2006542
+2K042344Excia Total Hip SystemAesculap, Inc.200519810
+2K040191Bicontact Hip Stem and Femoral HeadAesculap2004267—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K103431Coren Total Hip SystemCorentec Co., Ltd.201111—
+3K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+3K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+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—
+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—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+3K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.200665—
+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—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+3K043079Bicontact Hip System with U-CapAesculap2004166—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+4K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+4K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+4K131354Renovis Bipolar Hip SystemRenovis Surgical Technologies, LLC20131—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+4K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+4K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+4K093472Trinity Acetabular SystemCorin USA20101171
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K083312Minihip StemCorin USA201015—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081023Evolis Total Knee SystemMedacta International S.A.2008781
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—