The US Food and Drug Administration (FDA) has granted 510(k) clearance for Exactech’s new Activit-E polyethylene for the Truliant knee replacement system.

Activit-E utilises chemically crosslinked polyethylene to achieve an optimised balance between material strength and toughness while removing the necessity for the gamma irradiation technique utilised in previous polyethylene generations.

The material has been developed to maintain active oxidative resistance as well as long-term high performance, including stabilisation and strength.

The company plans to deliver the first products at the start of the third quarter this year for select customers in the US. It plans to initiate global expansion next year.

Exactech large joints business unit SVP and CMO 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 antioxidants that is intended to further our primary goal of providing immense benefits to our patients.”

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By GlobalData

Harris Orthopaedic Laboratory director at Massachusetts General Hospital Orhun Muratoglu has pioneered this new generation of polyethylene.

Muratoglu invented the first crosslinked polyethylene, as well as several vitamin E antioxidant polyethylene products for various orthopaedic enterprises.

Muratoglu said: “We replaced gamma radiation crosslinking with peroxide crosslinking and stabilised 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.”