510(k) Report

Devices descending from K100359

145 later devices reach Darco Headed Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+1K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+1K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+1K132893Edge Orthopaedics Bite Compression ScrewIcon Orthopaedic Concepts Dba Edge Orthopaedics20130—
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+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—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+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—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+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—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, 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—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—