510(k) Report

Devices descending from K973309

126 later devices reach Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191—
+1K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC20184—
+1K133842Tyber Medical Trauma ScrewTyber Medical, LLC201423—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+1K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.200738—
+2K253042Tyber Medical Trauma ScrewTyber Medical, 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—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc.20221—
+2K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+2K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+2K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.20200—
+2K192974Tyber Medical Trauma ScrewTyber Medical, LLC20201—
+2K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.20190—
+2K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K170571Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix ScrewTyber Medical, LLC20170—
+2K153575Tyber Medical Trauma ScrewTyber Medical, LLC201612—
+2K153180Tyber Medical MST Trauma ScrewTyber Medical, LLC20152—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K151418Monster Screw SystemParagon 28201527—
+2K141401Easy OutFeet For Life Podiatry Center20150—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+2K130590Aap Cannulated Screw 2.0Aap Implantate AG20130—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+2K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+2K082574Maxtorque Mini Cannulated Screw SystemOrthohelix Surgical Designs, Inc.200833
+2K080649Pogo ScrewFxdevices200815—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K252901Tyber Medical Trauma ScrewTyber Medical, LLC20250—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+3K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+3K230908Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+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—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K172785Conquest FNSmith & Nephew20178—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K162171S4 Screw System™Subchondral Solutions20173—
+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
+3K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+3K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC20161—
+3K152686Conquest FNSmith & Nephew201612—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K150871ForeFoot STP SystemTornier, Inc.20150—
+3K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+3K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+3K092189Pogo ScrewFxdevices20091—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—