510(k) Report

Devices descending from K962011

738 later devices reach Synthes 7.0/7.3 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+2K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+2K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Medical Design, LLC201235—
+2K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K111316Aap Cannulated ScrewsAap Implantate AG201139—
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG2008180—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+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—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+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—
+3K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K233008Cannulated Headless Bone ScrewsAap Implantate AG20240—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+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—
+3K230817TORPEDO Implant System®Deltacor GmbH20240—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K231831TiLink-L Joint Fusion SystemSurgentec20232—
+3K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+3K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—