US-based medical device company Exactech has received the US Food and Drug Administration (FDA) 510(k) approval for a new Activit-E polyethylene, used with its Truliant knee replacement system.

The Activit-E is designed to offer an optimised balance of material strength and toughness through chemically crosslinked polyethylene.

The new knee replacement polyethylene eliminates the need for gamma irradiation technology, which is used in previous generations of polyethylene.

Its material is designed to maintain active oxidative resistance and long-term, high-performance, strength and stabilisation, said the US-based medical device company.

Exactech large joints business unit CMO and SVP Adam Hayden said: “After years of research and development in polyethylene, Activit-E represents a breakthrough achievement for Exactech.

“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.”

Exactech said that its new-gen polyethylene is created by Orhun Muratoglu, director of the Harris Orthopaedic Laboratory at Massachusetts General Hospital in Boston.

Muratoglu developed the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for major orthopaedic companies.

The Truliant Knee System is a high-performance, comprehensive platform that provides solutions to address clinical challenges in primary and revision total knee replacement.

The system leverages Exactech’s core principles and applies advanced surgical technologies to help deliver reproducible clinical outcomes in a streamlined procedure.

Muratoglu added: “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.”