22 Aug Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene
GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced 510(k) clearance from the U.S. Food and Drug Administration for its new, advanced Activit-E™ polyethylene for the Truliant® knee replacement system.
“After years of research and development in polyethylene, Activit-E represents a breakthrough achievement for Exactech,” said Adam Hayden, CMO and SVP, Large Joints Business Unit at 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.”
Activit-E brings an optimized balance of material strength and toughness through chemically crosslinked polyethylene, while eliminating the need for gamma irradiation technology used in previous generations of polyethylene. The material is designed to maintain active oxidative resistance and long-term, high-performance, including strength and stabilization.
This new generation polyethylene is the latest, first-of-a-kind innovation by Orhun Muratoglu, Ph.D., Director of the Harris Orthopaedic Laboratory at Massachusetts General Hospital in Boston. Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopaedic companies.
“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.
The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S. customers. Global expansion will begin in 2024.
Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, Vumedi, YouTube, Instagram and Twitter. With Exactech by your side, you’ve got EXACTLY what you need.
Senior Marketing Communications Manager
SOURCE: Business Wire, August 21 2023
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