510(k) Report

Devices descending from K043536

342 later devices reach Navitrack System - S&N Image Free Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+1K103829Kneealign SystemOrthalign, Inc.201139—
+1K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG2006126—
+1K060556Brigit Surgical DeviceZimmer, Inc.2006128—
+1K060336Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc.2006913
+2K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+2K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+2K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+2K140331Orthalign Plus SystemOrthalign, Inc.201429—
+2K122326Smarttools Knee SystemZimmer201232
+2K102990Brainlab KneeBrainlab AG201171
+2K110054Navitrack System - OS Knee Universal, Cas Same Incision Tibia ReferenceZimmer Cas201192
+2K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+2K083872Imns Medacta Navigation SystemMedacta International S.A.200914—
+2K082267Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc.20081—
+2K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+2K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+2K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+2K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+2K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+3K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+3K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+3K252847NextAR Hip PlatformMedacta International S.A.20260—
+3K223351Naviswiss KneeNaviswiss AG20230—
+3K220652Knee 3Brainlab AG20220—
+3K202750Knee+Pixee Medical20218—
+3K192653PerseusOrthokey Italia S.R.L.20200—
+3K193559NextAR TKA PlatformMedacta Inernational SA202012—
+3K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+3K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+3K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+3K141601Iassist Knee SystemZimmer Cas20142—
+3K121936NaviopfsBlue Belt Technologies, Inc.2012222
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K101791Rosa Surgical DeviceMedtech S.A.S201012612
+3K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc.20101—
+3K100314Imns Medacta Navigation System,33.221000USMedacta International S.A.201013—
+3K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+3K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+3K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc.20090—
+3K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+3K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K220104Knee+Pixee Medical20227—
+4K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+4K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+4K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+4K210153NextAR RSA PlatformMedacta International S.A.202151
+4K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+4K202152NextAR TKA PlatformMedacta International S.A.202011—
+4K193307HIP7Brainlab AG20200—
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K172522Mazor XMazor Robotics, Ltd.20170—
+4K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+4K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+4K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+4K151511ROSA SpineMedtech S.A20161093
+4K151359ROSA BrainMedtech S.A201520Class I
+4K143420SYMBIS Surgical SystemImris, Inc.20150—
+4K140596NAVIOBlue Belt Technologies, Inc.201421—
+4K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+4K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+4K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+4K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+5K250477NextAR (TM) SpineMedacta International S.A.20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K232140OTS HipOrtoma AB202421
+5K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+5K232176STELLAR KneePolarisar, Inc.20230—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+5K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+5K230789Knee+Pixee Medical20235—
+5K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+5K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+5K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+5K182848ROSA ONE Spine applicationMedtech S.A201910—
+5K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+5K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+5K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+5K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+5K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+5K143668NavioBlue Belt Technologies, Inc.201520—
+5K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+5K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+5K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+5K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+5K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+5K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+5K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+5K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501