iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
US Nationwide distribution in the state of GA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0672-2020