510(k) Report

Devices descending from K050438

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K083009Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000Stryker Leibinger GmbH & Co KG20091—
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+3K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+3K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+3K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+3K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K252847NextAR Hip PlatformMedacta International S.A.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K252322SIros-X SystemGenesys Spine20250—
+3K251282StealthStation S8 Spine SoftwareMedtronic Navigation, Inc.20252—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+3K250477NextAR (TM) SpineMedacta International S.A.20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K242054OptimMRI (v2)Rebrain, Sas20240—
+3K233725Spine Navigation SystemMedivis, Inc.20240—
+3K241625Anatase Navi Disposable InstrumentRemex Medical Corp.20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K233513Remex Spine Surgery Navigation System IIRemex Medical Corp.20244—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+3K230195Neo ADVISE softwareComerge AG20240—
+3K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+3K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K230700RIWOtrack Navigation SystemFiagon GmbH20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231611HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies20230—
+3K230415Cadwell GuardianCadwell Industries, Inc.20230—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+3K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+3K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+3K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K230989Rod Registration FrameNu Vasive, Incorporated20230—
+3K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K222291Paradigm SystemProprio, Inc.20233—
+3K230783Anatase Spine Surgery Navigation SystemRemex Medical Corp.20235—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K222355PathKeeper SystemPathkeeper Surgical, Ltd.20230—
+3K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K222753SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation20221—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+3K213034SpineAR SNAPSurgical Theater, Inc.20222—
+3K213989Cranial EM SystemBrainlab AG20221—
+3K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220348Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-VRemex Medical Corporation20226—