510(k) Report

Devices descending from K200888

11 later devices reach OMNIBotics Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231172ApolloKneeCorin U.S.A. Limited20230—
+1K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+2K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+2K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+2K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+3K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+3K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+4K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+4K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+4K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+4K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—