510(k) Report

Devices descending from K060468

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+1K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+1K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+2K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+2K110021Dash HipBrainlab AG201147—
+2K110204Brainlab TraumaBrainlab AG201127—
+2K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+2K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+3K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+3K193307HIP7Brainlab AG20200—
+3K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+3K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+3K140331Orthalign Plus SystemOrthalign, Inc.201429—
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+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—
+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—
+4K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+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—
+5K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+5K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+5K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+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—
+5K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+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—
+5K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+6K261852OTS HipOrtoma AB20260—
+6K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K203751OMNIVision systemCorin USA20210—
+6K203205Navigated Spine InstrumentsStryker Spine20218—
+6K192653PerseusOrthokey Italia S.R.L.20200—
+6K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+6K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+6K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+6K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+6K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+6K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+6K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+6K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+7K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+7K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+7K242616Lantern® HipOrthalign, Inc.20241—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K223351Naviswiss KneeNaviswiss AG20230—
+7K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+7K202307Activ FuseNewclip Technics20200—
+7K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+7K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+7K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+7K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+7K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+7K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+7K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K260546Q Pedicle InstrumentsK2m, Inc.20260—
+8K252873Q Interbody InstrumentsK2m, Inc.20260—
+8K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+8K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+8K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—