510(k) Report

Devices descending from K062146

99 later devices reach Uni Knee Surgetics Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+1K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+1K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+2K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+2K121936NaviopfsBlue Belt Technologies, Inc.2012222
+2K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+2K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+2K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+3K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+3K140596NAVIOBlue Belt Technologies, Inc.201421—
+3K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+3K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+3K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+3K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+4K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+4K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+4K210153NextAR RSA PlatformMedacta International S.A.202151
+4K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+4K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+4K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+4K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+4K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+4K143668NavioBlue Belt Technologies, Inc.201520—
+4K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+4K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+5K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+5K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+5K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+5K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+5K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+5K152574NavioBlue Belt Technologies, Inc.201519—
+5K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+6K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+6K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+6K231172ApolloKneeCorin U.S.A. Limited20230—
+6K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+6K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+6K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+6K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K160537NavioBlue Belt Technologies, Inc.201618—
+7K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+7K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+7K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+7K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+7K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+7K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+7K170360NAVIOBlue Belt Technologies, Inc.201717—
+8K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+8K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+8K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+8K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+8K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+8K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+8K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+8K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+8K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+8K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+8K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+9K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+9K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+9K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+9K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+9K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+9K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+9K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+9K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+9K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+9K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+9K191223NAVIOBlue Belt Technologies, Inc.201915—
+10K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+10K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+10K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+10K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+11K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+11K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+11K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+12K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+12K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+13K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+13K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+14K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+15K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+16K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+17K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+18K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601