Implanet Gains FDA Clearance for MADISON Total Knee

By Julie A. Vetalice

Implanet Gains FDA Clearance for MADISON Total Knee

Implanet received FDA 510(k) clearance to market the cemented version of its Madison total knee. This is the first step towards clearance of the company's complete total knee replacement range.

The clearance was supported by clinical results, including data collected over seven years and 17,000 implants. Further, the clearance is a key component in the company's partnership with KICO Knee Innovation Company for distribution of the MADISON knee, initially in the U.S. and Australia, as signed in 2018.

Obtaining this marketing clearance also represents a key component of the partnership and distribution contract with KICo (Knee Innovation Company) signed and announced in November 2018.

Ludovic Lastennet, CEO of Implanet, said, "This clearance is fully in line with the strategic development of our partnership with KICo that aims to target, for Implanet’s knee division, the high-potential markets of Australia and the United States through KICo’s Florida-based subsidiary."

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory