510(k) Report

Devices descending from K102903

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203381Dynanail Mini HybridMedShape, Inc.202141
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+4K193366T2 ICFStryker GmbH20201—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+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—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+5K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+5K190230iFuse Implant System®SI-BONE, Inc.201957—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+6K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251365OptumSI Implant SystemSi Solutions, LLC20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—