Cartiva has received 510(k) approval from the US Food and Drug Administration for its ProxiFuse Hammertoe Correction System.
Specifically developed for hammertoe fusion, the system will be used for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Cartiva president and CEO Timothy Patrick said: "We are very excited to announce the clearance of the ProxiFuse, the first intramedullary hammertoe implant designed to maintain continuous bone to bone contact through an innovative suture locking system.
"We believe our system resolves many of the shortcomings of existing products, such as fixation and stability, and could provide an attractive option for patients suffering from this painful condition."
The system features Tiny Nitinol anchor that is connected by a self-locking suture fiber and small PEEK body, which offers rigidity across the fusion site.
According to the company, PEEK helps clinicians to monitor the healing progress with X-ray images, a process that can be obscured by standard radiopaque metal implants.
Cartiva develops and markets solutions for osteoarthritis, cartilage damage and other musculoskeletal conditions.