510(k) Report

Devices descending from K002053

427 later devices reach Navitrak System-Optical Option, Model 900.004 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031156Navitrack System-Fluorospine, Model 900.005Orthosoft, Inc.200336—
+1K022364Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc.200382—
+1K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc.2002363—
+2K160284JointPointJointpoint, Inc.201621—
+2K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+2K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+2K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+2K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG2006126—
+2K060336Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc.2006913
+2K031196Surgetics Ortho Kneelogics Navigation SystemPraxim2005149—
+2K043536Navitrack System - S&N Image Free KneeOrthosoft, Inc.2005342—
+2K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+2K030827Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc.2003461
+3K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+3K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+3K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+3K203651CuptimizeCuptimize, Inc.20213—
+3K200350MyHip Planner & VerifierMedacta International S.A.20201—
+3K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+3K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+3K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+3K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+3K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+3K103829Kneealign SystemOrthalign, Inc.201139—
+3K102990Brainlab KneeBrainlab AG201171
+3K110054Navitrack System - OS Knee Universal, Cas Same Incision Tibia ReferenceZimmer Cas201192
+3K083872Imns Medacta Navigation SystemMedacta International S.A.200914—
+3K082267Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc.20081—
+3K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+3K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+3K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+3K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+3K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+3K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+3K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+3K062146Uni Knee Surgetics Navigation SystemPraxim S.A200699—
+3K060556Brigit Surgical DeviceZimmer, Inc.2006128—
+3K053542Surgetics Ortho Osteologics Navigation SystemPraxim S.A20060—
+3K060282Total Knee Surgetics Navigation SystemPraxim S.A2006147—
+3K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+3K041369Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc.2004411
+3K032917Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc.20033—
+4K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+4K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+4K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+4K221725Advanced MyHip PlannerMedacta International S.A.20230—
+4K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+4K213922FX SPSPixee Medical20222—
+4K220652Knee 3Brainlab AG20220—
+4K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+4K202750Knee+Pixee Medical20218—
+4K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+4K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+4K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+4K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+4K121936NaviopfsBlue Belt Technologies, Inc.2012222
+4K122326Smarttools Knee SystemZimmer201232
+4K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+4K100742Exactech GPSBlue Ortho201020—
+4K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+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—
+4K100314Imns Medacta Navigation System,33.221000USMedacta International S.A.201013—
+4K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+4K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+4K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+4K091411Kneealign SystemOrthalign, Inc.200941—
+4K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+4K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc.20090—
+4K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+4K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+4K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+4K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+5K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+5K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+5K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+5K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+5K252214AIAS CephalonMetamorphosis GmbH20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+5K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+5K223351Naviswiss KneeNaviswiss AG20230—
+5K220104Knee+Pixee Medical20227—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+5K193307HIP7Brainlab AG20200—
+5K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+5K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711