510(k) Report

Devices descending from K010783

484 later devices reach 2.0/2.4 Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+1K101030Modification to HBS Headless Bone ScrewBiopro, Inc.2010402
+1K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006310—
+1K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20051452
+2K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+2K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+2K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics20151—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K151021OsteoMed Cannulated Screw SystemOsteomed Corp.201516—
+2K140283Osteomed Extremifuse SystemOsteomed20140—
+2K130412Osteomed Extremifuse SystemOsteomed20134—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K111536Metasurg Digifuse ImplantMetasurg201130—
+2K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+2K080398SI Joint Fusion SystemSI-BONE, Inc.2008144—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+3K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+3K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+3K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+3K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+3K151718iFuse Implant SystemSI-BONE, Inc.201585—
+3K150875iFuse Implant SystemSI-BONE, Inc.201586—
+3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+3K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141—
+3K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+3K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+3K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+3K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+3K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+3K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+3K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K123850Ifuse Implant SystemSI-BONE, Inc.2013134—
+3K122959Hammer Toe ImplantTrilliant Surgical, Ltd.2012221
+3K122074Ifuse Implant SystemSI-BONE, Inc.2012139—
+3K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+3K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+3K102528N-Force Fixation SystemInnovision, Inc.20115—
+3K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+3K110838Ifuse Implant SystemSI-BONE, Inc.2011143—
+3K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+3K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K230546SignexOsteonic Co., Ltd.20242—