510(k) Report

Devices descending from K090953

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+1K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+2K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+2K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+2K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+3K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+3K231172ApolloKneeCorin U.S.A. Limited20230—
+3K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+4K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+4K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+4K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+5K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+5K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+6K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+6K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—