510(k) Report

Devices descending from K082320

302 later devices reach Darco Small Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K202307Activ FuseNewclip Technics20200—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K191009Arsenal Plating SystemTrilliant Surgical20192—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K173641Activ AnkleNewclip Technics20183—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+3K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC20161—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+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—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+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—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K213214Xpert WristNewclip Technics20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—