510(k) Report

Devices descending from K871046

214 later devices reach Compass Stereotactic Positioning System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964229Regulus NavigatorCompass Intl., Inc.199766—
+1K963256Neuromate Stereotactic SystemIntegrated Surgical Systems, S.A.1997182—
+2K133573Fiagon Navigation SystemFiagon GmbH201428—
+2K060556Brigit Surgical DeviceZimmer, Inc.2006128—
+2K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+2K991081Frameless NeuromateIntegrated Surgical Systems, Inc.1999180—
+2K981315NavitrackOrthosoft, Inc.199836—
+3K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+3K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+3K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+3K162176Fiagon Navigation SystemFiagon GmbH20164—
+3K161701CARTO ENT SystemBiosense Webster20163—
+3K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+3K150473FlexPointer 1.5 mmFiagon GmbH20152—
+3K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+3K132755Neuromate Frameless Gen IIRenishaw Mayfield Sarl20141—
+3K101791Rosa Surgical DeviceMedtech S.A.S201012612
+3K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+3K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+3K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+3K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+3K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+3K041477PathfinderArmstrong Healthcare Limited20040—
+4K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+4K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+4K201174TruDi CuretteAcclarent, Inc.20200—
+4K193453TruDi ProbeAcclarent, Inc.20200—
+4K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+4K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+4K192397TruDi Navigation SystemBiosense Webster202011
+4K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+4K180206neuromate Gen IIIRenishaw Mayfield Sarl20180—
+4K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+4K172522Mazor XMazor Robotics, Ltd.20170—
+4K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+4K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+4K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+4K160369GuideWireFiagon GmbH20163—
+4K151511ROSA SpineMedtech S.A20161093
+4K151359ROSA BrainMedtech S.A201520Class I
+4K143420SYMBIS Surgical SystemImris, Inc.20150—
+4K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+4K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+4K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+4K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+5K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+5K190532TruDi NAV WireAcclarent, Inc.20190—
+5K182848ROSA ONE Spine applicationMedtech S.A201910—
+5K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+5K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+5K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K123548The Artas SystemRestoration Robotics, Inc.201314
+5K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+5K110911Renaissance SystemMazor Robotics, Ltd.201124—
+5K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+6K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+6K221028SURGIVISIO DeviceEcential Robotics20227—
+6K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+6K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+6K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053