510(k) Report

Devices descending from K163338

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

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