FDA Clears Exactech's Polyethylene for the Total Ankle System

Activit-E is a highly crosslinked polyethylene with vitamin E antioxidant stabilization.

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Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced 510(k) clearance for its Activit-E polyethylene for the Vantage Total Ankle System. This announcement comes on the heels of the Activit-E clearance for the Truliant Knee System, which was announced last month.

“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,” said Exactech’s Director of Engineering, Foot and Ankle, Matt Hamilton.

Activit-E is a highly crosslinked polyethylene with vitamin E antioxidant stabilization. Its unique manufacturing process replaces gamma irradiation crosslinking with peroxide crosslinking and adds vitamin E to provide strength, flexibility, toughness, and oxidative stability. This technology also ensures patients will be able to access the clinical benefits of highly crosslinked polyethylene despite the anticipated shortage of gamma radiation for crosslinking.

“Our new polyethylene brings an optimized balance of material strength and toughness through its ability to maintain active oxidative resistance and long-term, high performance,” said Devan Carter, Exactech’s foot and ankle marketing director. “We look forward to seeing how Activit-E, coupled with our data-driven total ankle system, can help patients nationwide get back to the activities they love.”

Activit-E was developed by Orhun Muratoglu, Ph.D., director of the Harris Orthopaedic Laboratory at Massachusetts General Hospital in Boston, and his team, including Ebru Oral, Ph.D, director of Biomaterials Research. Muratoglu and his team invented the first generation highly crosslinked polyethylene, and Muratoglu, together with Oral, pioneered Vitamin E stabilization in highly crosslinked polyethylenes that are in clinical use worldwide.

Pilot launch for Activit-E is expected in the first quarter of 2024.

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