FDA clears text

FDA Clears Conformis’ Knee Replacement System

February 24, 2021

The FDA has given 510(k) clearance for Conformis’ iTotal Identity Cruciate Retaining knee replacement system.

The system features customized femoral and tibial fitting to avoid overhang, under-coverage and sizing compromises. Its shape, which is customized for each patient, gives the knee the potential to feel and move more naturally, the company said.

The knee replacement system is installed using a simplified delivery model that includes a pre-sterilized kit and a single reusable instrument tray.

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