Suture system from Acuitive Technologies granted FDA clearance
The FDA has granted Acuitive Technologies Inc. 510(k) clearance to market its Citrefix Knotless Suture Anchor System, according to a press release.
The system is intended to assist the attachment of tissue to bone during orthopedic procedures.
“This FDA clearance for the Citrefix system is an important milestone for Acuitive,” Michael McCarthy, managing partner of Acuitive Technologies Inc., said in the 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.”
Citrefix uses Citregen technology, a bioresorbable synthetic biomaterial, to attach tissue to bone . The Citregen material “releases molecules essential to bone formation throughout its bioresorption process leaving behind a biomimetic ceramic structure to be metabolized by the host tissue,” according to the company.
The company expects to commercialize the system by the middle of 2021.