510(k) Report

Devices descending from K964229

66 later devices reach Regulus Navigator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133573Fiagon Navigation SystemFiagon GmbH201428—
+1K981315NavitrackOrthosoft, Inc.199836—
+2K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+2K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+2K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+2K162176Fiagon Navigation SystemFiagon GmbH20164—
+2K161701CARTO ENT SystemBiosense Webster20163—
+2K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+2K150473FlexPointer 1.5 mmFiagon GmbH20152—
+2K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+2K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+3K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+3K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+3K201174TruDi CuretteAcclarent, Inc.20200—
+3K193453TruDi ProbeAcclarent, Inc.20200—
+3K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+3K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+3K192397TruDi Navigation SystemBiosense Webster202011
+3K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+3K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+3K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+3K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+3K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+3K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+3K160369GuideWireFiagon GmbH20163—
+3K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+3K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+3K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+4K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+4K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+4K190532TruDi NAV WireAcclarent, Inc.20190—
+4K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+4K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+4K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+5K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+5K110911Renaissance SystemMazor Robotics, Ltd.201124—
+5K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+6K182359HipCheckStryker Corp.20181—
+6K173946ADAPT for Gamma3Stryker GmbH20182—
+6K120812RenaissanceMazor Robotics, Ltd.2012211
+6K113228Renaissance SystemMazor Robotics, Ltd.201123—
+7K230045HipCheckStryker Corp.20230—
+7K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+7K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+7K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+8K202749ADAPT for Gamma3Stryker GmbH20200—
+8K163221Mazor XMazor Robotics, Ltd.201719—
+9K180307Mazor XMazor Robotics, Ltd.201817—
+9K172522Mazor XMazor Robotics, Ltd.20170—
+10K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+11K200935Mazor XMazor Robotics, Ltd.202015—
+12K203005Mazor XMazor Robotics, Ltd.2020141
+13K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+13K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+14K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+14K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+14K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+14K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+14K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+15K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+15K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+15K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+15K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+15K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+16K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+16K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—