Acuitive Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its CITRESPLINE and CITRELOCK ligament reconstruction devices.

Featuring patented CITREGEN biomaterial technology, the CITRESPLINE / CITRELOCK system has been developed to rigidly engage tendons and ligaments within a bone tunnel while protecting the integrity of the soft tissue during insertion of the device.

The devices are developed for use during orthopaedic surgeries to fix ligament or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle, and foot.

With the support of an orthopaedic distribution partner, Acuitive is planning to commercialise the CITRESPLINE and CITRELOCK system.

Acuitive Technologies managing director Michael McCarthy said: “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.

“The CITRESPLINE/CITRELOCK System is the third innovation from our robust pipeline of CITREGEN based products that is cleared for commercialization in the US.”

CITREGEN is a synthetic biomaterial developed on a molecular level to oversee tissue regeneration by replicating the intrinsic cellular biochemical and structural support network.

Citrate, which is a main component of the synthetic biomaterial, is a naturally occurring anti-microbial and anti-inflammatory molecule that plays a significant role in bone regeneration.

It helps to regulate cellular metabolic processes and the formation of mineral structures.

CITREGEN is said to release molecules required for bone formation across its bioresorption process and allows to metabolise the biomimetic ceramic structure by the host tissue.

The CITREGEN material technology is developed using a licenced intellectual property (IP) portfolio from both Northwestern University and The Pennsylvania State University.

In February, Acuitive Technologies secured 510(k) clearance from the FDA for its CITREFIX Knotless Suture Anchor System with CITREGEN material technology.