Acuitive Technologies announced today that it received FDA 510(k) clearance for its CitreLock interference screw system.
CitreLock with CitreGen material technology, a next-generation thermoset bioresorbable synthetic polymer, is designed to attach tissue during orthopedic surgeries, including the fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee and foot extremities, according to a news release.
Allendale, N.J.-based Acuitive’s CitreGen biomaterial is designed on a molecular level to guide tissue regeneration by replicating the cellular biochemical and structural support network. It is comprised mainly of citrate, an anti-microbial and anti-inflammatory molecule that aids in bone regeneration.
CitreLock with CitreGen will be offered with both reusable surgical instruments or single-use instruments, as well as in a full range of device sizes. The company plans to commercialize the system in early 2021 with an orthopedic distribution partner.
“The FDA clearance of the CITRELOCK system is an important milestone for Acuitive,” Acuitive managing partner Michael McCarthy said in the news release. “It’s the first biomaterial from our robust pipeline that is cleared for commercialization in the U.S.”