510(k) Report

Devices descending from K080943

215 later devices reach Synthes 4.5 MM and 6.5 MM Headless Compression Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+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—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203381Dynanail Mini HybridMedShape, Inc.202141
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K193366T2 ICFStryker GmbH20201—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K153378Monster BITE Screw SystemParagon 28201522—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—