510(k) Report

Devices descending from K060282

147 later devices reach Total Knee Surgetics Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100742Exactech GPSBlue Ortho201020—
+1K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+1K091411Kneealign SystemOrthalign, Inc.200941—
+1K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+1K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+1K062146Uni Knee Surgetics Navigation SystemPraxim S.A200699—
+2K152764Exactech GPSBlue Ortho2016191
+2K103829Kneealign SystemOrthalign, Inc.201139—
+2K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+2K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+2K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+2K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+3K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+3K193618ExactechGPS SystemBlue Ortho202021
+3K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+3K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+3K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+3K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+3K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+3K121936NaviopfsBlue Belt Technologies, Inc.2012222
+3K122326Smarttools Knee SystemZimmer201232
+3K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+3K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+4K223351Naviswiss KneeNaviswiss AG20230—
+4K213877ExactechGPS® SystemBlue Ortho20221—
+4K192653PerseusOrthokey Italia S.R.L.20200—
+4K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+4K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+4K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K141601Iassist Knee SystemZimmer Cas20142—
+4K140596NAVIOBlue Belt Technologies, Inc.201421—
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+4K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+4K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+4K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+5K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+5K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+5K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+5K233299ExactechGPS® SystemBlue Ortho20240—
+5K231172ApolloKneeCorin U.S.A. Limited20230—
+5K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+5K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+5K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+5K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+5K143668NavioBlue Belt Technologies, Inc.201520—
+5K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+5K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+6K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+6K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+6K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+6K152574NavioBlue Belt Technologies, Inc.201519—
+6K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+7K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K160537NavioBlue Belt Technologies, Inc.201618—
+8K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+8K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+8K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+8K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+8K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+8K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+8K170360NAVIOBlue Belt Technologies, Inc.201717—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+9K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—