510(k) Report

Devices descending from K111994

161 later devices reach Smith & Nephew Cannulated Screws and Washers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+1K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+1K202326BESPA Charcot SystemBespa Global, LLC20210—
+1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+1K193029Conquest FNSmith & Nephew, Inc.202010—
+1K172785Conquest FNSmith & Nephew20178—
+1K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+1K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+1K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+1K152686Conquest FNSmith & Nephew201612—
+1K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+1K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+1K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+1K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K182677DynaNail MiniMedShape, Inc.20195—
+2K182989AURORA™ Screw SystemMiRus, LLC20180—
+2K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+2K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+2K150871ForeFoot STP SystemTornier, Inc.20150—
+2K151418Monster Screw SystemParagon 28201527—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203381Dynanail Mini HybridMedShape, Inc.202141
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K193366T2 ICFStryker GmbH20201—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K153378Monster BITE Screw SystemParagon 28201522—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—