510(k) Report

Devices descending from K983831

611 later devices reach VECTORVISION2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260976NeuroBlate SystemMonteris Medical20261—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+7K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+7K242616Lantern® HipOrthalign, Inc.20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+7K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K230415Cadwell GuardianCadwell Industries, Inc.20230—
+7K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223351Naviswiss KneeNaviswiss AG20230—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K222750Yomi Robotic SystemNeocis, Inc.20223—
+7K214065ROSA ONE Brain applicationMedtech S.A.S20221—
+7K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+7K200655FibroScan® 630Echosens20200—
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+7K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+7K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+7K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+7K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+7K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+7K143668NavioBlue Belt Technologies, Inc.201520—
+7K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+7K122326Smarttools Knee SystemZimmer201232
+8K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K260546Q Pedicle InstrumentsK2m, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K252873Q Interbody InstrumentsK2m, Inc.20260—
+8K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+8K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+8K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K231018Yomi Robotic SystemNeocis, Inc.20232—
+8K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+8K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—