Medical device company Hyalex Orthopaedics Inc reported on Wednesday the receipt of the breakthrough device designation from the US Food and Drug Administration (FDA) for the HYALEX Cartilage System for repairing cartilage defects and restore function for patients with loss of knee articular cartilage and bone requiring surgery.

Unlike other cartilage solutions requiring multiple surgeries and regeneration, the company's HYALEX Cartilage is a biomimetic materials platform designed to provide a single-step, off-the-shelf, high strength, low friction, low wear solution.

The company has published evidence of preservation of the cartilage counter-face with its HYALEX Cartilage and is protected by more than 17 patents and trademarks worldwide.

According to the company, the US FDA's Breakthrough Device Programme is a selective, voluntary programme reserved for certain medical technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or condition.