510(k) Report

Devices descending from K003496

345 later devices reach Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc.20154—
+3K150121Zimmer Periarticular Plating SystemZimmer, Inc.201509
+3K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Zimmer, Inc.201412—
+3K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+3K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+3K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+4K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K250647SImmetry+ SystemSivantage20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+4K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+4K213815SiJoin®T3Vgi Medical, Inc.20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+4K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203381Dynanail Mini HybridMedShape, Inc.202141
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053