510(k) Report

Devices descending from K013106

101 later devices reach 2 Piece Modular Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20218—
+1K193233Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)20200—
+1K120578Accolade II Hip StemHowmedica Osteonics2012461
+1K103479Novel Tapered Hip StemStryker Corp.201153—
+1K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+1K022549Restoration Modular SystemHowmedica Osteonics Corp.2002543
+2K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K211703Insignia Hip StemStryker Orthopaedics20217—
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+2K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+2K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+2K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+2K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+2K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+2K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+2K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+2K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+2K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+2K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+2K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+2K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243444Bioceram Azul® HeadKyocera Corporation20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+3K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+3K220405Amis K LongMedacta International S.A.20220—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+3K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+3K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+3K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+3K170845MiniMAXMedacta International S.A.201771
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+3K151739Revision Femoral StemLima Corporate S.P.A.20157—
+3K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+3K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+3K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+3K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+3K113556Wagner Cone Prosthesis SystemZimmer GmbH201291
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K212327M-Vizion MonoblocMedacta International S.A.20221—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+4K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+4K192352MiniMAXMedacta International S.A.20192—
+4K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+4K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH20191—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+4K161226Revision Femoral StemLima Corporate S.P.A.20170—
+4K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH20168—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+5K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K201673SMS Cementless StemMedacta International S.A.20203—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K160011H-Max S stemLima Corporate S.P.A.20161—