510(k) Report

Devices descending from K063298

246 later devices reach Osteomed Headless Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+1K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+1K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+1K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+1K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+1K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+1K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+1K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+2K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+2K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K210159IntraLock SystemFusion Orthopedics, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K193029Conquest FNSmith & Nephew, Inc.202010—
+2K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+2K172785Conquest FNSmith & Nephew20178—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+2K152686Conquest FNSmith & Nephew201612—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+2K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+2K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+3K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+3K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—