New vitamin E antioxidant PE approved for knee replacement use

Exactech, a developer and producer of innovative implants for joint replacement surgery, announced 510(k) clearance from the US Food and Drug Administration for its new Activit-E polyethylene (PE) for the Truliant knee replacement system.

Activit-E is a crosslinked PE with vitamin E antioxidant. The PE is peroxide crosslinked and stabilized with vitamin E. The material is designed to maintain active oxidative resistance and long-term, high-performance, including strength and stabilization.

Exactech’s new Activit-E Knee Replacement Polyethylene.

This new generation PE is the latest innovation by Orhun Muratoglu, Ph.D., Director of the Harris Orthopedic Laboratory at Massachusetts General Hospital in Boston. Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E antioxidant PE for leading orthopedic companies.

Through replacing gamma radiation crosslink with peroxide crosslink, the chemically crosslinked PE brings an optimized balance of material strength, toughness and flexibility, which is ultimately useful in total knee arthroplasty.

Eliminating the need for gamma irradiation technology used in previous generation PE also addresses the looming shortage problem of gamma radiation for crosslink.

The first products for Activit-E will launch in the beginning of Q3 2023 for selected US customers while global expansion will begin in 2024.