Acuitive Technologies this week announced that it received FDA 510(k) clearance for its Citrespline and Citrelock ligament reconstruction devices.
The two systems are designed to firmly engage tendons and ligaments with a bone tunnel while preserving the integrity of the soft tissue during insertion of the device, according to the company. Citrespline and Citrelock are intended for use in orthopedic surgeries for the fixation of ligament or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle and foot.
“This FDA clearance for the Citrespline and Citrelock system is a significant milestone that allows Acuitive to compete in the sports medicine market using innovative materials and designs that protect the soft tissue during insertion while improving fixation strength,” Acuitive Technologies managing partner Michael McCarthy said in a news release. “The Citrespline/Citrelock System is the third innovation from our robust pipeline of Citregen based products that is cleared for commercialization in the U.S.”
Citrespline and Citrelock have the company’s Citregen technology, which is a synthetic biomaterial designed on a molecular level to guide tissue regeneration by replicating the intrinsic cellular biochemical and structural support network. The main component, citrate, is a natural occurring anti-microbial and anti-inflammatory molecule that helps in bone regeneration. It regulates cellular metabolic processes and the formation of mineral structures, according to Acuitive Technologies. Citregen releases molecules that are essential for bone formation to leave behind a biomimetic ceramic structure that can be metabolized by the host tissue.
Acuitive Technologies said it plans to commercialize Citrespline and Citrelock with an orthopedic distribution partner.