510(k) Report

Devices descending from K002053

427 later devices reach Navitrak System-Optical Option, Model 900.004 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K152764Exactech GPSBlue Ortho2016191
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K141601Iassist Knee SystemZimmer Cas20142—
+5K140596NAVIOBlue Belt Technologies, Inc.201421—
+5K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+5K110911Renaissance SystemMazor Robotics, Ltd.201124—
+5K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+5K101791Rosa Surgical DeviceMedtech S.A.S201012612
+5K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+5K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K232140OTS HipOrtoma AB202421
+6K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+6K232176STELLAR KneePolarisar, Inc.20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+6K230789Knee+Pixee Medical20235—
+6K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+6K203751OMNIVision systemCorin USA20210—
+6K193618ExactechGPS SystemBlue Ortho202021
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+6K182359HipCheckStryker Corp.20181—
+6K173946ADAPT for Gamma3Stryker GmbH20182—
+6K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K172522Mazor XMazor Robotics, Ltd.20170—
+6K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+6K151511ROSA SpineMedtech S.A20161093
+6K151359ROSA BrainMedtech S.A201520Class I
+6K143420SYMBIS Surgical SystemImris, Inc.20150—
+6K143668NavioBlue Belt Technologies, Inc.201520—
+6K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+6K120812RenaissanceMazor Robotics, Ltd.2012211
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K113228Renaissance SystemMazor Robotics, Ltd.201123—
+6K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+6K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+6K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+6K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250086OTS HipOrtoma AB202511
+7K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+7K233899Knee+Pixee Medical20244—
+7K230045HipCheckStryker Corp.20230—
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K213877ExactechGPS® SystemBlue Ortho20221—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+7K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+7K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+7K182848ROSA ONE Spine applicationMedtech S.A201910—
+7K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+7K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+7K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+7K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+7K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+7K152574NavioBlue Belt Technologies, Inc.201519—
+7K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+7K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+7K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+7K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+7K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+7K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+7K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+7K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+7K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261852OTS HipOrtoma AB20260—
+8K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—