510(k) Report

Devices descending from K030827

46 later devices reach Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041369Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc.2004411
+1K032917Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc.20033—
+2K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+2K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+2K140331Orthalign Plus SystemOrthalign, Inc.201429—
+2K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+2K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+3K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+3K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+3K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+3K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+3K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+3K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+3K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+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—
+4K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+4K223351Naviswiss KneeNaviswiss AG20230—
+4K203751OMNIVision systemCorin USA20210—
+4K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+4K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+4K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+5K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+5K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K242616Lantern® HipOrthalign, Inc.20241—
+6K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+6K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+6K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+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—
+8K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+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—