510(k) Report

Devices descending from K991081

180 later devices reach Frameless Neuromate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120812RenaissanceMazor Robotics, Ltd.2012211
+5K113228Renaissance SystemMazor Robotics, Ltd.201123—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K230045HipCheckStryker Corp.20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K214065ROSA ONE Brain applicationMedtech S.A.S20221—
+6K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+6K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+6K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+6K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+7K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+7K202749ADAPT for Gamma3Stryker GmbH20200—
+7K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+7K163221Mazor XMazor Robotics, Ltd.201719—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+8K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+8K180307Mazor XMazor Robotics, Ltd.201817—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+9K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+9K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+10K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+10K200935Mazor XMazor Robotics, Ltd.202015—
+11K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+11K203005Mazor XMazor Robotics, Ltd.2020141
+12K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+12K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+12K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+13K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+13K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+13K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+13K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+13K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+13K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+14K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601
+14K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+14K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+14K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+15K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—