510(k) Report

Devices descending from K810258

509 later devices reach Proximal Fermoral Hip Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998508—
+2K033871IM Total FemurBiomet, Inc.20041—
+2K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20035053
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+3K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+3K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company201179—
+3K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+3K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc.200738—
+3K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+3K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005289—
+3K042051Arcomxl Polyethylene LinersBiomet, Inc.20053551
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190276Provident II Hip StemStelkast, Inc.20192—
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+4K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+4K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+4K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+4K122773Cross-Over Acetabular Shell & LinerStelkast Company201261
+4K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+4K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+4K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165—
+4K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286—
+4K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K201733Provident II Hip StemsGlobus Medical, Inc.20210—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+5K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+5K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+5K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+5K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+5K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+5K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+5K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+5K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+5K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009153—
+5K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+5K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+5K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+5K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—