510(k) Report

Devices descending from K022364

82 later devices reach Navitrack System Total Hip Replacement,Model 900.200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160284JointPointJointpoint, Inc.201621—
+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—
+1K030827Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc.2003461
+2K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+2K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+2K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+2K203651CuptimizeCuptimize, Inc.20213—
+2K200350MyHip Planner & VerifierMedacta International S.A.20201—
+2K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+2K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+2K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+2K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+2K041369Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc.2004411
+2K032917Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc.20033—
+3K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+3K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K221725Advanced MyHip PlannerMedacta International S.A.20230—
+3K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+3K213922FX SPSPixee Medical20222—
+3K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+3K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+3K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+3K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+3K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+3K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+3K140331Orthalign Plus SystemOrthalign, Inc.201429—
+3K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+3K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+4K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+4K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+4K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+4K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+4K252214AIAS CephalonMetamorphosis GmbH20250—
+4K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+4K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+4K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+4K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+4K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+4K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+4K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+4K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc.20101—
+5K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+5K223351Naviswiss KneeNaviswiss AG20230—
+5K203751OMNIVision systemCorin USA20210—
+5K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+5K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+5K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+5K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K192653PerseusOrthokey Italia S.R.L.20200—
+6K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+6K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+6K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+6K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+7K242616Lantern® HipOrthalign, Inc.20241—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+7K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+7K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+7K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+8K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+8K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+8K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+8K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+9K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+9K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+9K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+9K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+9K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+9K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+9K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+10K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+10K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+11K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—