510(k) Report

Devices descending from K050438

944 later devices reach Stealthstation System Update through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+3K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc.20222Class I
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K220146VisARNovarad Corporation20220—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+3K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+3K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K211188xvision Spine system (XVS)Augmedics, Ltd.202181
+3K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K202750Knee+Pixee Medical20218—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203816DeGen Navigated InstrumentationDegen Medical20211—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K2105557D Surgical System - Drill Guide7D Surgical, Inc.20210—
+3K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203639StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc.20215—
+3K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical…7D Surgical, Inc.20200—
+3K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+3K200791Navigation Enabled IntrumentsMedos International SARL20205—
+3K193559NextAR TKA PlatformMedacta Inernational SA202012—
+3K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+3K201327NavLock TrackersMedtronic Navigation20202—
+3K200935Mazor XMazor Robotics, Ltd.202015—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+3K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.20195—
+3K1921407D Surgical System7D Surgical, Inc.20193—
+3K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+3K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K192304SIS Software Version 3.6.0Surgical Information Sciences, Inc.20195—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191012Navigated Pedicle Access KitIzi Medical Products, LLC20191—
+3K1832767D Surgical System7D Surgical, Inc.20190—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K182848ROSA ONE Spine applicationMedtech S.A201910—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+3K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+3K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+3K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+3K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172522Mazor XMazor Robotics, Ltd.20170—
+3K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+3K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K163221Mazor XMazor Robotics, Ltd.201719—
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap…Stryker Corporation20173—
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K153240Styrker OrthoMap Express Knee SystemStryker Corporate201617—
+3K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+3K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc.20162Class I
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+3K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+3K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate201422—
+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—