510(k) Report

Devices descending from K040368

180 later devices reach Vectorvision Hip 3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+1K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+1K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+1K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+1K072716Vector Vision HipBrainlab AG200784—
+1K072573Vectorvision Hip and Hip SRBrainlab AG20070—
+1K063028Vectorvision Hip SRBrainlab AG200611—
+1K060727Vectorvision HipBrainlab AG200671—
+1K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp20060—
+1K060468Vectorvision HipBrainlab AG2006154—
+1K052213Navigation SW Hip 3.1 on CIBrainlab AG2005170—
+1K052178Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc.20052—
+2K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+2K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+2K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+2K110021Dash HipBrainlab AG201147—
+2K110204Brainlab TraumaBrainlab AG201127—
+2K072271Stryker Navigation System Infinitus Hip Resurfacing ModuleStryker Corp.20070—
+2K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+2K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+2K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+2K071135Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc.20070—
+3K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+3K193307HIP7Brainlab AG20200—
+3K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+3K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+3K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+3K140331Orthalign Plus SystemOrthalign, Inc.201429—
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+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—
+3K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+3K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+4K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+4K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+4K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+4K242569Mixed Reality Spine NavigationBrainlab AG20250—
+4K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+4K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+4K232140OTS HipOrtoma AB202421
+4K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+4K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+4K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+4K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+4K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+4K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+4K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+5K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+5K250086OTS HipOrtoma AB202511
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+5K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+5K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+5K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+5K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+5K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+6K261852OTS HipOrtoma AB20260—
+6K203751OMNIVision systemCorin USA20210—
+6K203205Navigated Spine InstrumentsStryker Spine20218—
+6K192653PerseusOrthokey Italia S.R.L.20200—
+6K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+6K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+6K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+6K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+6K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+6K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+6K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+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
+7K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+7K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+7K242616Lantern® HipOrthalign, Inc.20241—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K223351Naviswiss KneeNaviswiss AG20230—
+7K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+7K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+7K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+7K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+7K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+7K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+7K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+7K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+7K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+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—
+8K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+8K260546Q Pedicle InstrumentsK2m, Inc.20260—