510(k) Report

Devices descending from K993762

338 later devices reach I.CO.S Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+7K162171S4 Screw System™Subchondral Solutions20173—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+7K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+7K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+7K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+7K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+7K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+7K150871ForeFoot STP SystemTornier, Inc.20150—
+7K151146N-Force Fixation SystemInnovision, Inc.20151—
+7K151418Monster Screw SystemParagon 28201527—
+7K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+7K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+7K150626Rush Medullary PinsZimmer, Inc.20150—
+7K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+7K142776Flow-ScrewFlow-Fx, LLC20151—
+7K132244N-Force Fixation SystemInnovision, Inc.20143—
+7K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+7K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+8K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+8K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K231860TDM Screw SystemTdm Co., Ltd.20240—
+8K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+8K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+8K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203381Dynanail Mini HybridMedShape, Inc.202141
+8K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+8K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+8K193366T2 ICFStryker GmbH20201—
+8K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+8K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+8K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+8K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+8K153378Monster BITE Screw SystemParagon 28201522—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—