510(k) Report

Devices descending from K945115

537 later devices reach Mallory-Head Modular Calcar Repacement Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.20033916
+1K000335Mallory-Head Modular Calcar Total Hip SystemBiomet, Inc.20000—
+1K980239Partnership Calcar Femoral ComponentsHowmedica, Inc.19980—
+1K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998508—
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+2K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.200538—
+2K033871IM Total FemurBiomet, Inc.20041—
+2K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20035053
+3K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+3K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+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
+3K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+3K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+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
+4K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K220405Amis K LongMedacta International S.A.20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K190100USTAR II SystemUnited Orthopedic Corporation201925
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+4K190276Provident II Hip StemStelkast, Inc.20192—
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K151739Revision Femoral StemLima Corporate S.P.A.20157—
+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
+4K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+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—
+5K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+5K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+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—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+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
+5K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+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
+5K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701