Exactech Granted FDA 510(k) Approval for Innovative Activit-E™ Polyethylene Used in Knee Replacements
Tuesday, August 22, 2023
Exactech, a renowned innovator specializing in implants, surgical instruments, and smart technologies for joint replacement surgeries, has announced a significant milestone. The U.S. Food and Drug Administration has granted 510(k) clearance for Exactech's latest creation, the Activit-E™ polyethylene, specifically designed for integration with the Truliant® knee replacement system. This achievement is the culmination of extensive research and development efforts aimed at advancing polyethylene technology, resulting in the remarkable Activit-E™.
Activit-E™ marks a pivotal point in Exactech's journey, signifying a substantial leap forward in the realm of highly crosslinked polyethylene. Distinguished by the infusion of vitamin E antioxidants, Activit-E™ underscores Exactech's core commitment to enhancing patient outcomes. Employing chemically crosslinked polyethylene, Activit-E™ strikes an optimal balance between material strength and resilience, rendering obsolete the previous reliance on gamma irradiation technology employed in earlier polyethylene iterations.
What truly sets Activit-E™ apart is its unwavering dedication to maintaining oxidative resistance, ensuring enduring, steadfast performance characterized by both strength and stability. Notably, this innovative polyethylene not only marks the advent of the first crosslinked polyethylene but also introduces a new era of multiple generations of antioxidant polyethylene enriched with vitamin E—an accomplishment that significantly impacts the field of orthopedics.
In addition to its technical ingenuity, Activit-E™ addresses a pressing concern—the impending scarcity of gamma radiation for crosslinking applications. This proactive approach guarantees patients ongoing access to the proven benefits of highly crosslinked polyethylene for their total joint replacements.
The introduction of Activit-E™ is scheduled for the early stages of Q3 2023, initially catering to a select group of clients in the U.S. As the year progresses, a global rollout is anticipated in 2024, making this groundbreaking innovation accessible to a wider international audience.