Acuitive Technologies yesterday said it received FDA 510(k) clearance for its Citregen knotless suture anchor.
Citrefix is designed to assist in the attachment of tissue to the bone during orthopedic surgeries, such as fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle and foot extremities.
“This FDA clearance for the Citrefix system is an important milestone for Acuitive,” managing partner Michael McCarthy said in a news release. “The Citrefix Knotless Suture Anchor System expands our reach in both the extremities and sports medicine Markets. It’s the second innovative product from our robust pipeline that is cleared for commercialization in the U.S.”
The Citrefix system features the company’s Citregen biomaterial that is designed on a molecular level to guide tissue regeneration by replicating the intrinsic cellular biochemical and structural support network. It releases molecules essential to bone formation throughout its bio resorption process to leave behind a bio mimic ceramic structure to be metabolized by the hose tissue.