510(k) Report

Devices descending from K133444

172 later devices reach Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+1K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+1K180523INTAI Surgery Navigation SystemIntai Technology Corporation20197—
+1K1810417D Surgical System Cranial Application7D Surgical, Inc.20186—
+1K1803527D Surgical System7D Surgical, Inc.20188—
+1K171651Excelsius GPSGlobus Medical, Inc.2017691
+1K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc.201739Class I
+1K162375Envision 3D: Image Guidance System7D Surgical, Inc.201621—
+1K151511ROSA SpineMedtech S.A20161093
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+2K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+2K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+2K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+2K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+2K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+2K240160EGPS Navigated InstrumentsAstura Medical20240—
+2K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+2K241625Anatase Navi Disposable InstrumentRemex Medical Corp.20240—
+2K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+2K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+2K233513Remex Spine Surgery Navigation System IIRemex Medical Corp.20244—
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+2K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+2K223558CUVIS-spineCurexo, Inc.20230—
+2K222291Paradigm SystemProprio, Inc.20233—
+2K230783Anatase Spine Surgery Navigation SystemRemex Medical Corp.20235—
+2K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+2K222355PathKeeper SystemPathkeeper Surgical, Ltd.20230—
+2K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+2K222753SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation20221—
+2K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K220348Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-VRemex Medical Corporation20226—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K201569CUVIS-spineCurexo, Inc.20212—
+2K2105557D Surgical System - Drill Guide7D Surgical, Inc.20210—
+2K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical…7D Surgical, Inc.20200—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K201175StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc.20208—
+2K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.20195—
+2K1921407D Surgical System7D Surgical, Inc.20193—
+2K191012Navigated Pedicle Access KitIzi Medical Products, LLC20191—
+2K1832767D Surgical System7D Surgical, Inc.20190—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K182848ROSA ONE Spine applicationMedtech S.A201910—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+2K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+2K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+2K172522Mazor XMazor Robotics, Ltd.20170—
+3K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+3K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+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—
+3K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+3K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K251315Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System IIRemex Medical Corp.20251—
+3K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+3K243258Paradigm SystemProprio, Inc.20252—
+3K242480FLASH EVD System (10-0002)7D Surgical ULC20240—
+3K243560Remex Spine Surgery Navigation InstrumentRemex Medical Corp.20240—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+3K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K230661Zeta Cranial Navigation SystemZeta Surgical20233—
+3K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+3K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222698CUVIS-spineCurexo, Inc.20220—
+3K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+3K213989Cranial EM SystemBrainlab AG20221—
+3K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+3K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+3K221028SURGIVISIO DeviceEcential Robotics20227—
+3K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+3K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+3K203639StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc.20215—
+3K200935Mazor XMazor Robotics, Ltd.202015—
+3K192173ROSA ONE Spine applicationMedtech S.A20190—
+3K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—