510(k) Report

Devices descending from K924018

580 later devices reach M3 Lag Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+1K011946The Spin Snap-Off ScrewNew Deal, S.A.20016—
+1K990019DRG Medium Screw SystemDolphin Medical Technologies, Inc.19990—
+1K973810DRG Large Screw SystemDolphin Medical Technologies, Inc.19980—
+1K972217Orthopedic Screw SystemFerguson Medical19970—
+1K962233Twist-Off ScrewLandos, Inc.199692—
+1K962236Scarf Thread-Head ScrewLandos, Inc.1996548—
+1K960533K3 Bone Screw SystemKinetikos Medical, Inc.199661—
+1K960537K2 Bone Screw SystemKinetikos Medical, Inc.199641—
+2K253108VEOFIX Snap Off ScrewSteps Ortho20260—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie20170—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+2K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+2K151418Monster Screw SystemParagon 28201527—
+2K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+2K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+2K070617Cannulated ScrewFournitures Hospitalieres Industrie20074—
+2K070039Memometal Fixos ScrewsMemometal Technologies200784—
+2K062352FRS ScrewDePuy Orthopaedics, Inc.2006527—
+2K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH20052—
+2K023365Leforte System Bone ScrewJeil Medical Corporation200320—
+3K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K211628MIS Precision Chevron Bunion SystemRelja Innovations, LLC20221—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+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—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+3K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+3K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+3K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+3K143146Nexis osteosynthesis snap-off screwsNovastep20152—
+3K143229Nexis osteosynthesis compressive screwsNovastep20153—
+3K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+3K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+3K131311Arix Foot SystemJeil Medical Corporation20139—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+3K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K262075Lapidus Screw KitRelja Innovations, LLC20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—