510(k) Report

Devices descending from K170011

126 later devices reach StealthStation S8 Spine Software v1.0.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+1K211254ARAI Surgical Navigation SystemSurgalign Spine Technologies20221—
+1K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+1K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+1K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+1K192663Joimax Intracs SystemJoimax GmbH20201—
+1K201189Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc.2020151
+1K190929xvision Spine system (XVS)Augmedics, Ltd.201931—
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+1K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+1K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+2K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+2K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+2K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+2K252847NextAR Hip PlatformMedacta International S.A.20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K251282StealthStation S8 Spine SoftwareMedtronic Navigation, Inc.20252—
+2K250477NextAR (TM) SpineMedacta International S.A.20250—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K233725Spine Navigation SystemMedivis, Inc.20240—
+2K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+2K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K230700RIWOtrack Navigation SystemFiagon GmbH20230—
+2K231611HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies20230—
+2K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+2K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+2K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+2K230989Rod Registration FrameNu Vasive, Incorporated20230—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K213034SpineAR SNAPSurgical Theater, Inc.20222—
+2K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+2K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+2K220146VisARNovarad Corporation20220—
+2K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K211188xvision Spine system (XVS)Augmedics, Ltd.202181
+2K202750Knee+Pixee Medical20218—
+2K193559NextAR TKA PlatformMedacta Inernational SA202012—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K200935Mazor XMazor Robotics, Ltd.202015—
+3K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+3K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+3K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+3K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K242569Mixed Reality Spine NavigationBrainlab AG20250—
+3K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.202411
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+3K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+3K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+3K220905xvision Spine SystemAugmedics, Ltd.20227—
+3K220104Knee+Pixee Medical20227—
+3K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+3K210153NextAR RSA PlatformMedacta International S.A.202151
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K202152NextAR TKA PlatformMedacta International S.A.202011—
+3K203005Mazor XMazor Robotics, Ltd.2020141
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.20250—
+4K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K241481xvision Spine SystemAugmedics, Ltd.20243—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K232176STELLAR KneePolarisar, Inc.20230—
+4K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+4K231284OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20231—
+4K230789Knee+Pixee Medical20235—
+4K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332