510(k) Report

Devices descending from K023651

148 later devices reach Vectorvision Cranial/Ent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101791Rosa Surgical DeviceMedtech S.A.S201012612
+1K083597Sonowand InviteSonowand AS20093—
+1K082060Cranial Image Guided Surgery SystemBrainlab AG200916—
+1K061224Lapdoc IRobodent GmbH20060—
+1K051734GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin…Ge Healthcare Technologies200501
+2K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+2K201752Disposable Pre-calibrated SuctionBrainlab AG20210—
+2K190250Microscope NavigationBrainlab AG20190—
+2K172820Microscope Navigation SoftwareBrainlab AG20181—
+2K172522Mazor XMazor Robotics, Ltd.20170—
+2K151511ROSA SpineMedtech S.A20161093
+2K151359ROSA BrainMedtech S.A201520Class I
+2K143420SYMBIS Surgical SystemImris, Inc.20150—
+2K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS20122—
+2K100038Disposable Reflective Marker SpheresBrainlab AG201023
+2K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Brainlab AG201010Class I
+3K231897NeuroAlign softwareMedivis, Inc.20250—
+3K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—
+3K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+3K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+3K182848ROSA ONE Spine applicationMedtech S.A201910—
+3K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+3K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+3K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K111443X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering20110—
+3K103192Navigation Marker, Reflective Marker SpheresIlumark GmbH20111—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+4K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+4K221028SURGIVISIO DeviceEcential Robotics20227—
+4K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+4K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+4K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+4K192173ROSA ONE Spine applicationMedtech S.A20190—
+4K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+5K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+5K231886SURGIVISIO DeviceEcential Robotics20236—
+5K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+5K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K200511ROSA ONE Brain applicationMedtech S.A20205Class I
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—