FDA Clears Hammertoe Correction System from Cartiva

Alpharetta, Ga.-based Cartiva Inc., which makes technology for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Proxifuse hammertoe correction system. The system is used for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The Proxifuse system combines several features into a single device. Tiny nitinol anchors on each side of the joint are secured into the bone, connected by a self-locking suture fiber. Once tightened, the Proxifuse system is designed to deliver continuous compression across the joint to be fused. A small PEEK (polyetheretherketone) body provides rigidity across the fusion site. PEEK, which is radiolucent, allows clinicians to monitor the healing progress with X-ray images, a process that can be obscured by standard radiopaque metal implants.

Hammertoes, deformities of the second, third or fourth toe that cause the toe to bend at the middle joint instead of pointing forward, are one of the most common deformities of the lesser toes. One of the more common surgical procedures to treat this condition is fusing the joint, in which the ends of the bone are cut and the toe is straightened. Pins, screws or other implants are used to keep the toe straight while the bone ends heal together. In the United States, approximately 600,000 annual surgical implant procedures are performed to treat hammertoes. While multiple fixation methods have been used to achieve a stable correction, the most common method has traditionally been the use of a pin-like device known as a Kirschner wire, or “K-wire.” K-wires have been associated with complications including broken hardware, loosening, bending, migration and pin tract infection. Furthermore, patient dissatisfaction can be high as the K-wire protrudes from the tip of the toe during the four to six week healing process.

“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,” said Timothy J. Patrick, president and CEO of Cartiva. “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.”