510(k) Report

Devices descending from K921274

644 later devices reach Metallic Toatal Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc.20024801
+1K000788Apex Modular Hip StemApex Surgical, LLC2000168—
+1K994286ZMR Hip System-Porous RevisionZimmer, Inc.200010511
+1K994038Modular Reach HipBiomet, Inc.199943—
+1K992667ZMR Hip System-Revision TaperZimmer, Inc.19991141
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K151739Revision Femoral StemLima Corporate S.P.A.20157—
+2K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+2K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+2K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+2K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+2K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+2K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+2K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005289—
+2K042989RX90 Low Profile Acetabular SystemBiomet, Inc.20051—
+2K042051Arcomxl Polyethylene LinersBiomet, Inc.20053551
+2K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+2K041950Apex K2 Hip SystemApex Surgical, LLC2004621
+2K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041—
+2K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+2K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.2003843
+2K031572ZMR Hip System-XL, Models 9921, 9922 and 9923Zimmer, Inc.2003286
+2K022463HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral…Biomet Orthopedics, Inc.200242—
+3K261576Icona Hip StemCorin, Ltd.20260—
+3K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+3K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+3K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K161226Revision Femoral StemLima Corporate S.P.A.20170—
+3K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20160—
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+3K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+3K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+3K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+3K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+3K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+3K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+3K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+3K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165—
+3K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286—
+3K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.200754
+3K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+3K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc.200671
+3K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+3K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.20050—
+3K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+3K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.200411—
+3K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.20033916
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K212327M-Vizion MonoblocMedacta International S.A.20221—
+4K220405Amis K LongMedacta International S.A.20220—
+4K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+4K201673SMS Cementless StemMedacta International S.A.20203—
+4K192236Fitmore Hip StemZimmer GmbH20191—
+4K190100USTAR II SystemUnited Orthopedic Corporation201925
+4K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+4K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191—