510(k) Report

Devices descending from K014154

281 later devices reach Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250304TITANEX Screw SystemsVilex, LLC20251—
+1K221342REDEMPTION Beaming SystemVilex, LLC20220—
+1K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.20200—
+1K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC20184—
+1K173286Cannulated Screw Internal Fixation SystemLife Spine, Inc.20170—
+1K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K150871ForeFoot STP SystemTornier, Inc.20150—
+1K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+1K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH20132—
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+1K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+2K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+2K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+2K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+2K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+2K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+2K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+2K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K160548MC-Subtalar (TM) IIMerete Medical GmbH20160—
+2K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+2K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K151418Monster Screw SystemParagon 28201527—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+2K140962Normed Vario Subtalar ScrewNormed Nedizin Technik GmbH20140—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+2K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+2K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+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—
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K210159IntraLock SystemFusion Orthopedics, LLC20210—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K172785Conquest FNSmith & Nephew20178—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691