510(k) Report

Devices descending from K102903

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+3K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+3K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182989AURORA™ Screw SystemMiRus, LLC20180—
+3K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+3K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K150871ForeFoot STP SystemTornier, Inc.20150—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+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—
+4K241895Cannulated PsiFGuardSpineguard20240—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+4K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+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—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—