510(k) Report

Devices descending from K992927

425 later devices reach Stealthstation Treatment Guidance Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.2016144Class I
+1K053610AbarisTraxtal Technologies, Inc.20062783
+1K051734GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin…Ge Healthcare Technologies200501
+2K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1Medtronic Navigation, Inc.20193Class I
+2K170011StealthStation S8 Spine Software v1.0.0Medtronic Navigation2017126—
+2K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+2K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc.201739Class I
+2K151414IQQA GuideEdda Technology20151—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K121498PercunavPhilips Health Care2012222—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+3K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+3K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+3K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+3K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+3K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+3K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+3K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc.20222Class I
+3K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+3K211254ARAI Surgical Navigation SystemSurgalign Spine Technologies20221—
+3K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+3K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K192663Joimax Intracs SystemJoimax GmbH20201—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K201175StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc.20208—
+3K201189Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc.2020151
+3K190929xvision Spine system (XVS)Augmedics, Ltd.201931—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+3K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K132087Percunav SystemPhilips Health Care20139—
+3K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+3K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+4K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+4K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K251282StealthStation S8 Spine SoftwareMedtronic Navigation, Inc.20252—
+4K250477NextAR (TM) SpineMedacta International S.A.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K233725Spine Navigation SystemMedivis, Inc.20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K230700RIWOtrack Navigation SystemFiagon GmbH20230—
+4K231976StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc.20231—
+4K231611HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies20230—
+4K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+4K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K213034SpineAR SNAPSurgical Theater, Inc.20222—
+4K213989Cranial EM SystemBrainlab AG20221—
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+4K220146VisARNovarad Corporation20220—
+4K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211188xvision Spine system (XVS)Augmedics, Ltd.202181
+4K202750Knee+Pixee Medical20218—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203639StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc.20215—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K200935Mazor XMazor Robotics, Ltd.202015—
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K153004Clear Guide SCENERGYClear Guide Medical20164—
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—