510(k) Report

Devices descending from K921308

472 later devices reach HG Multilock Hip Prosthesis W/ TI-Nidium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+4K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K131986Corin Minihip StemCorin USA20133—
+4K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+4K123392Avenir Muller StemZimmer GmbH2013414
+4K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.201291
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+4K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH201101
+4K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+4K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+4K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+4K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+4K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083—
+4K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+4K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc.20073Class I
+4K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+4K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611—
+4K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690—
+4K042344Excia Total Hip SystemAesculap, Inc.200519810
+4K043079Bicontact Hip System with U-CapAesculap2004166—
+4K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+4K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+5K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG20220—
+5K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+5K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+5K220405Amis K LongMedacta International S.A.20220—
+5K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+5K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+5K190100USTAR II SystemUnited Orthopedic Corporation201925
+5K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH20193—
+5K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+5K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+5K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+5K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+5K170845MiniMAXMedacta International S.A.201771
+5K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+5K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K162775Legion Cone SystemSmith & Nephew, Inc.201752
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+5K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K151739Revision Femoral StemLima Corporate S.P.A.20157—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K141327Minima S SystemLima Corporate S.P.A.20145—