510(k) Report

Devices descending from K972228

255 later devices reach Meridian Titanium Femoral Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110290Exeter Hip StemHowmedica Osteonics Corp.2011371
+1K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+1K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200210137
+1K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp.2000763
+1K993768Citation TMZF HA StemHowmedica Osteonics Corp.200022412
+2K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20218—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K193233Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)20200—
+2K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+2K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+2K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+2K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+2K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+2K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+2K120578Accolade II Hip StemHowmedica Osteonics2012461
+2K103479Novel Tapered Hip StemStryker Corp.201153—
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+2K053528Short Citation Femoral StemStryker Orthopaedics20060—
+2K052542Accolade RPS Hip StemStryker Orthopaedics20050—
+2K051741Accolade HFX Femoral StemStryker Orthopaedics200518—
+2K022549Restoration Modular SystemHowmedica Osteonics Corp.2002543
+2K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000150—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+3K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+3K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+3K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+3K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics2015212
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+3K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+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
+3K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+3K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+3K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K220405Amis K LongMedacta International S.A.20220—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—