Acuitive Technologies received FDA 510(k) clearance to market the CITRELOCK™ Interference Screw System with CITREGEN™ material, a new-generation FDA-cleared thermoset bioresorbable synthetic polymer. CITRELOCK is indicated for fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle and foot extremities.
This is the company's first FDA 510(k) clearance. CITRELOCK will be offered with both reusable or single-use instruments, in a full range of device sizes. Product launch is slated for early 2021.
CITREGEN is a synthetic biomaterial designed to replicate the intrinsic cellular biochemical and structural support network. Its main component, citrate, is a naturally occurring anti-microbial and anti-inflammatory molecule that regulates cellular metabolic processes and the formation of mineral structures.
CITREGEN leaves behind a biomimetic ceramic structure to be metabolized by host tissue. Bioresorption avoids the potential for bulk degradation and chronic inflammation as opposed to current biodegradable polymers.
"The FDA clearance of the CITRELOCK system is an important milestone for Acuitive," said Michael McCarthy, Managing Partner, Acuitive Technologies, Inc. "It's the first biomaterial from our robust pipeline that is cleared for commercialization in the U.S."