Acuitive Technologies Gains FDA 510(k) Clearance for CITREFIX Knotless Suture Anchor

By Julie A. Vetalice

Acuitive Technologies Gains FDA 510(k) Clearance for CITREFIX Knotless Suture Anchor

Acuitive Technologies was granted FDA 510(k) clearance to market the CITREFIX™ Knotless Suture Anchor featuring CITREGEN™ bioresorbable synthetic polymer. Acuitive plans to commercialize CITREFIX in mid-year 2021 with an orthopedic distribution partner.

This represents the company's second FDA clearance, following the CITREGEN CITRELOCK Tendon Interference Screw last year.

CITREFIX is intended to support the attachment of tissue to bone during fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle and foot.

CITREGEN releases molecules essential to bone formation during bioresorption, leaving behind a biomimetic ceramic structure to be metabolized by the host tissue. This process avoids the potential for bulk degradation and chronic inflammation.

"This FDA clearance for the CITREFIX system is an important milestone for Acuitive," said Michael McCarthy, Managing Partner, Acuitive Technologies. "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."

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory