510(k) Report

Devices descending from K101791

126 later devices reach Rosa Surgical Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172522Mazor XMazor Robotics, Ltd.20170—
+1K151511ROSA SpineMedtech S.A20161093
+1K151359ROSA BrainMedtech S.A201520Class I
+1K143420SYMBIS Surgical SystemImris, Inc.20150—
+2K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+2K182848ROSA ONE Spine applicationMedtech S.A201910—
+2K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+2K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+3K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+3K221028SURGIVISIO DeviceEcential Robotics20227—
+3K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+3K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+3K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K192173ROSA ONE Spine applicationMedtech S.A20190—
+3K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+4K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+4K231886SURGIVISIO DeviceEcential Robotics20236—
+4K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+4K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K200511ROSA ONE Brain applicationMedtech S.A20205Class I
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+5K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K214065ROSA ONE Brain applicationMedtech S.A.S20221—
+6K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—