Company: Blue Belt Technologies, Inc
Date of Enforcement Report: 10/05/2023
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (22.214.171.124) Product Number: ROB10299
CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis
Blue Belt Technologies, Inc
VOLUME OF PRODUCT IN COMMERCE:
US Nationwide distribution.