510(k) Report

Devices descending from K161591

78 later devices reach QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+1K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+1K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+1K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+1K171651Excelsius GPSGlobus Medical, Inc.2017691
+1K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+2K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+2K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+2K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+2K240160EGPS Navigated InstrumentsAstura Medical20240—
+2K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+2K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+2K223558CUVIS-spineCurexo, Inc.20230—
+2K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K201569CUVIS-spineCurexo, Inc.20212—
+2K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K200896Solstice CCILife Spine, Inc.20200—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K183381Navigation Enabled InstrumentsStryker20191—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222698CUVIS-spineCurexo, Inc.20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—