510(k) Report

Devices descending from K941366

241 later devices reach Osteonics Omnifit AD-HA Hip Stem Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041170Secur-Fit HA and Secur-Fit Plus Hip StemsHowmedica Osteonics Corp.2004182
+1K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp.2000763
+1K993768Citation TMZF HA StemHowmedica Osteonics Corp.200022412
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+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—
+2K053528Short Citation Femoral StemStryker Orthopaedics20060—
+2K052542Accolade RPS Hip StemStryker Orthopaedics20050—
+2K051741Accolade HFX Femoral StemStryker Orthopaedics200518—
+2K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200210137
+2K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000150—
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+3K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+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—
+3K213129Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20218—
+3K211703Insignia Hip StemStryker Orthopaedics20217—
+3K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+3K193233Restoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)20200—
+3K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+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—
+3K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+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—
+3K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+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—
+3K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+3K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp.2013301
+3K122853Novel Fit and Fill StemHowmedica Osteonics Corp.201322—
+3K090757Biomet Modular Femoral Revision SystemBiomet, Inc.20093718
+3K060437Excia Total Hip System with U-CapAesculap, Inc.200690—
+3K022549Restoration Modular SystemHowmedica Osteonics Corp.2002543
+3K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.2001688
+4K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+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—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+4K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+4K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+4K170845MiniMAXMedacta International S.A.201771
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+4K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+4K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K130063Arcos Trochanter ButtonBiomet, Inc.20133—
+4K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp20107—
+4K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+4K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+4K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.200861—
+4K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+4K062383Unisyn HA Plasma Modular HipHayes Medical, Inc.20061—
+4K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+4K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+4K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K220405Amis K LongMedacta International S.A.20220—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+5K192352MiniMAXMedacta International S.A.20192—