510(k) Report

Devices descending from K081232

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+2K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+2K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+3K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+4K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+4K231172ApolloKneeCorin U.S.A. Limited20230—
+4K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+5K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+5K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+5K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+6K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+6K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+7K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+7K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—