Exactech Gains 510(k) for Activit-E Polyethylene in Ankle Replacement

Exactech received FDA 510(k) clearance to market Activit-E polyethylene for the Vantage Total Ankle System.

Activit-E is a next-generation highly crosslinked polyethylene with vitamin E antioxidant stabilization. Its manufacturing process replaces gamma irradiation crosslinking with peroxide crosslinking and adds vitamin E to provide strength, flexibility, toughness and oxidative stability.

Pilot launch for Activit-E is expected in 1Q24.

Source: Exactech