510(k) Report

Devices descending from K931681

337 later devices reach Cannulated Navicular Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+8K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+8K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+8K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+8K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+8K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+8K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+8K182677DynaNail MiniMedShape, Inc.20195—
+8K182989AURORA™ Screw SystemMiRus, LLC20180—
+8K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+8K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+8K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+8K171651Excelsius GPSGlobus Medical, Inc.2017691
+8K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+8K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+8K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+8K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+8K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+8K150871ForeFoot STP SystemTornier, Inc.20150—
+8K151146N-Force Fixation SystemInnovision, Inc.20151—
+8K151418Monster Screw SystemParagon 28201527—
+8K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+8K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+8K150626Rush Medullary PinsZimmer, Inc.20150—
+8K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+8K142776Flow-ScrewFlow-Fx, LLC20151—
+8K132244N-Force Fixation SystemInnovision, Inc.20143—
+8K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+8K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+9K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+9K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—
+9K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K240160EGPS Navigated InstrumentsAstura Medical20240—
+9K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+9K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+9K223558CUVIS-spineCurexo, Inc.20230—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+9K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+9K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+9K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+9K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+9K201569CUVIS-spineCurexo, Inc.20212—
+9K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+9K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+9K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K203381Dynanail Mini HybridMedShape, Inc.202141
+9K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+9K193366T2 ICFStryker GmbH20201—
+9K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+9K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+9K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+9K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+9K173556Injection ScrewBiedermann Medtech, Inc.20180—
+9K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+9K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+9K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+9K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+9K153378Monster BITE Screw SystemParagon 28201522—
+10K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+10K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+10K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+10K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+10K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+10K233256Robotic Integration InstrumentsDePuy Synthes20240—
+10K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+10K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+10K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+10K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—