510(k) Report

Devices descending from K021932

755 later devices reach Synthes 6.5 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+3K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K241895Cannulated PsiFGuardSpineguard20240—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+3K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+3K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+3K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K231831TiLink-L Joint Fusion SystemSurgentec20232—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—