510(k) Report

Devices descending from K963256

182 later devices reach Neuromate Stereotactic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060556Brigit Surgical DeviceZimmer, Inc.2006128—
+1K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+1K991081Frameless NeuromateIntegrated Surgical Systems, Inc.1999180—
+2K132755Neuromate Frameless Gen IIRenishaw Mayfield Sarl20141—
+2K101791Rosa Surgical DeviceMedtech S.A.S201012612
+2K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+2K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+2K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+2K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+2K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+2K041477PathfinderArmstrong Healthcare Limited20040—
+3K180206neuromate Gen IIIRenishaw Mayfield Sarl20180—
+3K172522Mazor XMazor Robotics, Ltd.20170—
+3K151511ROSA SpineMedtech S.A20161093
+3K151359ROSA BrainMedtech S.A201520Class I
+3K143420SYMBIS Surgical SystemImris, Inc.20150—
+3K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+3K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+3K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+3K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+4K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+4K182848ROSA ONE Spine applicationMedtech S.A201910—
+4K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+4K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K123548The Artas SystemRestoration Robotics, Inc.201314
+4K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+4K110911Renaissance SystemMazor Robotics, Ltd.201124—
+4K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+5K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+5K221028SURGIVISIO DeviceEcential Robotics20227—
+5K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+5K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+5K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K192173ROSA ONE Spine applicationMedtech S.A20190—
+5K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182359HipCheckStryker Corp.20181—
+5K173946ADAPT for Gamma3Stryker GmbH20182—
+5K173358ARTAS SystemRestoration Robotics, Inc.20180—
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K120812RenaissanceMazor Robotics, Ltd.2012211
+5K113228Renaissance SystemMazor Robotics, Ltd.201123—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+6K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+6K230045HipCheckStryker Corp.20230—
+6K231886SURGIVISIO DeviceEcential Robotics20236—
+6K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+6K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—