510(k) Report

Devices descending from K083483

70 later devices reach Brainlab Hip Unlimited, CI Hip Unlimited through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+1K110021Dash HipBrainlab AG201147—
+1K110204Brainlab TraumaBrainlab AG201127—
+2K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+2K193307HIP7Brainlab AG20200—
+2K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+2K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+2K140331Orthalign Plus SystemOrthalign, Inc.201429—
+2K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+3K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+3K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+3K242569Mixed Reality Spine NavigationBrainlab AG20250—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+3K232140OTS HipOrtoma AB202421
+3K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+3K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+3K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+3K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+3K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+3K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+4K250086OTS HipOrtoma AB202511
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+4K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+4K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+4K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K261852OTS HipOrtoma AB20260—
+5K203751OMNIVision systemCorin USA20210—
+5K203205Navigated Spine InstrumentsStryker Spine20218—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+5K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+5K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+5K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+5K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+6K242616Lantern® HipOrthalign, Inc.20241—
+6K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+6K223351Naviswiss KneeNaviswiss AG20230—
+6K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+6K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+6K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+6K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+7K260546Q Pedicle InstrumentsK2m, Inc.20260—
+7K252873Q Interbody InstrumentsK2m, Inc.20260—
+7K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+7K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+7K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+7K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+7K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+8K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+8K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+8K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+8K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+8K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+8K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+8K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+8K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+8K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+8K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+9K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+9K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+10K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—