510(k) Report

Devices descending from K871046

214 later devices reach Compass Stereotactic Positioning System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192173ROSA ONE Spine applicationMedtech S.A20190—
+6K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182359HipCheckStryker Corp.20181—
+6K173946ADAPT for Gamma3Stryker GmbH20182—
+6K173358ARTAS SystemRestoration Robotics, Inc.20180—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+6K120812RenaissanceMazor Robotics, Ltd.2012211
+6K113228Renaissance SystemMazor Robotics, Ltd.201123—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+7K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+7K230045HipCheckStryker Corp.20230—
+7K231886SURGIVISIO DeviceEcential Robotics20236—
+7K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+7K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K200511ROSA ONE Brain applicationMedtech S.A20205Class I
+7K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+7K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+8K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K214065ROSA ONE Brain applicationMedtech S.A.S20221—
+8K202749ADAPT for Gamma3Stryker GmbH20200—
+8K163221Mazor XMazor Robotics, Ltd.201719—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+9K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+9K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+9K180307Mazor XMazor Robotics, Ltd.201817—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+10K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+10K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+10K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+11K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+11K200935Mazor XMazor Robotics, Ltd.202015—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+12K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+12K203005Mazor XMazor Robotics, Ltd.2020141
+13K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—