510(k) Report

Devices descending from K974558

508 later devices reach Salvage/Onocology Hip and Total Femur System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033871IM Total FemurBiomet, Inc.20041—
+1K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20035053
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+2K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company201179—
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+2K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+2K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc.200738—
+2K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+2K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005289—
+2K042051Arcomxl Polyethylene LinersBiomet, Inc.20053551
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K190276Provident II Hip StemStelkast, Inc.20192—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+3K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+3K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+3K122773Cross-Over Acetabular Shell & LinerStelkast Company201261
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K112802Pipeline Total Hip SystemPipeline Orthopedics201253—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+3K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+3K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165—
+3K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286—
+3K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+4K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+4K201733Provident II Hip StemsGlobus Medical, Inc.20210—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+4K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+4K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+4K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+4K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+4K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+4K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+4K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009153—
+4K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+4K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+4K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+4K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+4K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—