Sam Brusco, Associate Editor09.21.23
Exactech has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Activit-E polyethylene for its Vantage total ankle system.
This clearance comes right on the heels of Activit-E’s clearance for the Truliant knee system in August.
Activit-E is Exactech’s next-gen, highly crosslinked polyethylene with vitamin E antioxidant stabilization. Its manufacturing process replaces gamma irradiation crosslinking with peroxide crosslinking, and the added vitamin E provides strength, flexibility, toughness, and oxidative stability, the company said.
The technology 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.
“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,” Exactech’s director of engineering for Foot and Ankle Matt Hamilton told the press.
The company said the pilot launch for Activit-E is in Q1 2024.
Earlier in September, Exactech completed the first knee replacement surgeries using its TriVerse primary knee.
This clearance comes right on the heels of Activit-E’s clearance for the Truliant knee system in August.
Activit-E is Exactech’s next-gen, highly crosslinked polyethylene with vitamin E antioxidant stabilization. Its manufacturing process replaces gamma irradiation crosslinking with peroxide crosslinking, and the added vitamin E provides strength, flexibility, toughness, and oxidative stability, the company said.
The technology 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.
“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,” Exactech’s director of engineering for Foot and Ankle Matt Hamilton told the press.
The company said the pilot launch for Activit-E is in Q1 2024.
Earlier in September, Exactech completed the first knee replacement surgeries using its TriVerse primary knee.