Implanet Gains Regulatory Clearance for MADISON Total Knee in Australia

By Julie A. Vetalice

Implanet Gains Regulatory Clearance for MADISON Total Knee in Australia

Implanet announced the clearance of its MADISON™ total knee prosthesis by the Therapeutic Goods Administration in Australia.

The approval is an integrated part of a distribution agreement with KICo to market the device in the U.S. and Australia. This milestone completes the eight international licenses covering the MADISON knee range, the FDA 510(k) clearance granted for marketing in the U.S. and CE Mark approval.

Ludovic Lastennet, CEO of Implanet, said, “This new clearance from the Australian Health Authority reinforces the clinical value of our proprietary technology for knee surgery and ensures the development of our business in one of the highest-potential markets. In line with our strategy to expand into new countries, this clearance follows the 510(k) from FDA and the CE marking that runs until May 2024, and paves the way for the Group to achieve new structural milestones.”

Product Labels: Knee Replacement

Tags: Regulatory