510(k) Report

Devices descending from K063408

34 later devices reach Ctlogics Navigations Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+1K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+2K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+2K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+3K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+3K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+3K210153NextAR RSA PlatformMedacta International S.A.202151
+3K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+3K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+4K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+4K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+4K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+4K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+4K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+5K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+5K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+5K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K231172ApolloKneeCorin U.S.A. Limited20230—
+5K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+6K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+6K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+6K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+7K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+7K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+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—