510(k) Report

Devices descending from K090949

176 later devices reach Synthes (Usa) 1.5MM Headless Compression Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230945Forma Medical Headless Compression ScrewForma Medical, Inc.20230—
+1K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K142581APTUS Foot SystemMedartis AG201522—
+1K143165Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…Zimmer, Inc.201572
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+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—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K191636APTUS Foot SystemMedartis AG20190—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151418Monster Screw SystemParagon 28201527—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+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—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.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—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+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—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+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—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+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—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—