Exactech has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Activit-E polyethylene for the VantageTotal Ankle System.
Last month, the company also obtained clearance from the FDA for Activit-E for the Truliant Knee System.
Activit-E, an advanced crosslinked polyethylene with vitamin E antioxidant stabilisation, utilises a unique manufacturing process for the replacement of gamma irradiation crosslinking with peroxide crosslinking.
This polyethylene also helps add vitamin E to provide toughness, strength, flexibility and oxidative stability.
The Activit-E pilot launch is scheduled for the first quarter of next year.
Massachusetts General Hospital’s Harris Orthopaedic Laboratory director Orhun Muratoglu, along with his team, including Biomaterials Research director Ebru Oral, developed the next-generation polyethylene.
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.”
Earlier this month, Exactech launched TriVerse, a new primary knee system that has treated its first cases of active knee replacement patients.
The new implant, which features anterior and posterior stabilised components, is completely made of well-crosslinked vitamin E polyethylene.
Exactech is focused on the development and marketing of orthopaedic implant devices and related surgical instruments. Its products are available in more than 30 markets in Latin America, Europe, Asia and the Pacific, in addition to the US.