510(k) Report

Devices descending from K991197

114 later devices reach Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250304TITANEX Screw SystemsVilex, LLC20251—
+1K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC20233—
+1K191289Bone Screw Line AdditionVilex IN Tennessee, Inc.20192—
+1K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC20184—
+1K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+1K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+1K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+1K101030Modification to HBS Headless Bone ScrewBiopro, Inc.2010402
+1K092440Ascension Cannulated Screw SystemAscension Orthopedics, Inc.20090—
+1K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.200738—
+1K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc.20065—
+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—
+2K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+2K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies20250—
+2K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+2K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+2K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.20200—
+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—
+2K151418Monster Screw SystemParagon 28201527—
+2K141401Easy OutFeet For Life Podiatry Center20150—
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+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—
+2K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+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—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+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
+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—
+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—
+3K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.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—
+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—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—