510(k) Report

Devices descending from K991081

180 later devices reach Frameless Neuromate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132755Neuromate Frameless Gen IIRenishaw Mayfield Sarl20141—
+1K101791Rosa Surgical DeviceMedtech S.A.S201012612
+1K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+1K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+1K041477PathfinderArmstrong Healthcare Limited20040—
+1K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+2K180206neuromate Gen IIIRenishaw Mayfield Sarl20180—
+2K172522Mazor XMazor Robotics, Ltd.20170—
+2K151511ROSA SpineMedtech S.A20161093
+2K151359ROSA BrainMedtech S.A201520Class I
+2K143420SYMBIS Surgical SystemImris, Inc.20150—
+2K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+2K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+2K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+2K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+2K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+2K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+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
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+3K123548The Artas SystemRestoration Robotics, Inc.201314
+3K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+3K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+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—
+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—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+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—
+4K173358ARTAS SystemRestoration Robotics, Inc.20180—
+4K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+4K110911Renaissance SystemMazor Robotics, Ltd.201124—
+4K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+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—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K200511ROSA ONE Brain applicationMedtech S.A20205Class I
+5K182359HipCheckStryker Corp.20181—
+5K173946ADAPT for Gamma3Stryker GmbH20182—
+5K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—