510(k) Report

Devices descending from K003496

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K193366T2 ICFStryker GmbH20201—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+4K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc.20150—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K141401Easy OutFeet For Life Podiatry Center20150—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K241895Cannulated PsiFGuardSpineguard20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+5K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—