FDA OKs Exactech’s Activit-E Knee Replacement Polyethylene

Exactech has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its new Activit-E polyethylene for the Truliant knee replacement system.
 
Activit-E, according to Exactech, balances material strength and toughness through chemically crosslinked polyethylene. The need for gamma irradiation technology used in previous polyethylene was also removed.
 
The material was engineered to maintain active oxidative resistance as well as long-term strength and stabilization. Exactech said the first Activit-E products will launch at the start of Q2 2023 for select U.S. customers, with global expansion planned to begin in 2024.
 
“After years of research and development in polyethylene, Activit-E represents a breakthrough achievement for Exactech,” Adam Hayden, CMO and SVP, Large Joints Business Unit at Exactech, told the press. “It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients.”
 
The new generation of polyethylene was a first-of-its kind innovation from Orhun Muratoglu, Ph.D., Director of the Harris Orthopaedic Laboratory at Massachusetts General Hospital in Boston. Muratoglu invented the first crosslinked polyethylene and first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopedic firms.
 
“We replaced gamma radiation crosslinking with peroxide crosslinking and stabilized the poly with vitamin E to provide strength, flexibility, and toughness where it is needed most: total knee arthroplasty. This technology also addressed the looming shortage of gamma radiation for crosslinking, ensuring that patients will continue to benefit from the clinically proven advantages of highly crosslinked polyethylene in total joints,” said Muratoglu.