US-based medical device company Exactech has received US Food and Drug Administration (FDA) 510(k) clearance for its Activit-E polyethylene for the Vantage Total Ankle System for ankle replacement.

Activit-E is a highly crosslinked polyethylene of the most recent generation stabilised with vitamin E antioxidants.

The polyethylene system is said the latest addition to Exactech’s Vantage ankle portfolio.

The FDA clearance follows the Activit-E clearance for the Truliant Knee System, which was announced last month.

It is said to have a distinctive manufacturing process that replaces gamma irradiation crosslinking with peroxide crosslinking and adds vitamin E to give strength, flexibility, toughness, and oxidative stability.

This technology also ensures that the clinical advantages of highly crosslinked polyethylene are also made available to patients despite the expected shortage of gamma radiation for crosslinking.

Exactech Foot and Ankle engineering director Matt Hamilton said: “We’re excited to bring Activit-E to the ankle portfolio. This advanced material gives us the best-wear performance we’ve tested combined with higher fracture toughness than other highly crosslinked vitamin E polyethylenes.

“Both are important factors when designing implants for a very active patient population.”

Activit-E was developed by Orhun Muratoglu, director of the Harris Orthopaedic Laboratory at Massachusetts General Hospital in Boston, and his team.

The pilot launch of the ankle replacement system is anticipated in the first quarter of 2024.

Exactech foot and ankle marketing director Devan Carter said: “Our new polyethylene brings an optimised balance of material strength and toughness through its ability to maintain active oxidative resistance and long-term, high performance.

“We look forward to seeing how Activit-E, coupled with our data-driven total ankle system1, can help patients nationwide get back to the activities they love.”