510(k) Report

Devices descending from K133444

172 later devices reach Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.20260—
+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—
+4K250879Paradigm SystemProprio, Inc.20251—
+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—
+4K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20242—
+4K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+4K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K231886SURGIVISIO DeviceEcential Robotics20236—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+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—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K212397StealthStation S8 Cranial v2.0Medtronic Navigation20214Class I
+4K203005Mazor XMazor Robotics, Ltd.2020141
+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—
+5K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K252950Paradigm SystemProprio, Inc.20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav20250—
+5K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+5K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+5K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+5K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253663Zeta Navigation SystemZeta Surgical, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+6K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+9K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+10K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+11K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+12K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+13K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601