510(k) Report

Devices descending from K151511

109 later devices reach ROSA Spine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182848ROSA ONE Spine applicationMedtech S.A201910—
+1K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+1K172522Mazor XMazor Robotics, Ltd.20170—
+1K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+2K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+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—
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+2K223558CUVIS-spineCurexo, Inc.20230—
+2K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+2K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+2K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+2K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+2K221028SURGIVISIO DeviceEcential Robotics20227—
+2K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+2K201569CUVIS-spineCurexo, Inc.20212—
+2K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+2K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K192173ROSA ONE Spine applicationMedtech S.A20190—
+2K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+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—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+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—
+3K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+3K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+3K231886SURGIVISIO DeviceEcential Robotics20236—
+3K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+3K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+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—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+4K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+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—
+5K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—