510(k) Report

Devices descending from K993768

224 later devices reach Citation TMZF HA Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053528Short Citation Femoral StemStryker Orthopaedics20060—
+1K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200210137
+1K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000150—
+2K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20218—
+2K193233Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)20200—
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+2K120578Accolade II Hip StemHowmedica Osteonics2012461
+2K103479Novel Tapered Hip StemStryker Corp.201153—
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+2K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+2K022549Restoration Modular SystemHowmedica Osteonics Corp.2002543
+2K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+3K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+3K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+3K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+3K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+3K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+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
+3K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+3K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+3K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+3K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+3K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+3K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+4K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+4K220405Amis K LongMedacta International S.A.20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+4K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+4K190100USTAR II SystemUnited Orthopedic Corporation201925
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+4K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+4K170845MiniMAXMedacta International S.A.201771
+4K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+4K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+4K151739Revision Femoral StemLima Corporate S.P.A.20157—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+4K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+4K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+4K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+4K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K113556Wagner Cone Prosthesis SystemZimmer GmbH201291
+4K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K083312Minihip StemCorin USA201015—
+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—
+4K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+5K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+5K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—