Sonoma Orthopedic Gets FDA Clearance for Intramedullary Nail System for Ankle Fractures

Buffalo Grove, Ill.-based Sonoma Orthopedic Products, which specializes in minimally invasive bone fracture repair, has received U.S. Food and Drug Administration 510(k) clearance for the intramedullary (within the bone canal) FibuLock nail.

The company claims that the system offers physicians a “new alternative” to surgically treat ankle fractures.

Fractures of the lower end of the fibula are one of the most common ankle fractures seen in hospitals. Such injuries are predominantly surgically repaired with plates that allow surgeons to anatomically realign most fractures and stabilize the ligaments through a four to six-inch incision. This alignment is critical in ankle fractures to prevent the development of arthritis. A plate aligns the fracture by being screwed to the outside of the broken bones just under the skin.

Due to the proximity to the skin, roughly 30 percent of patients complain about plate discomfort and frequently request a second surgery for removal, according to data cited by the company. Additionally, surgeons often are concerned the large incisions necessary to implant plates can increase the risk of infection in the many patients with poor foot circulation. Incision-site infections are reported to occur in 5 to 17 percent of cases and may lead to a devastating downward spiral for some patients, especially poorly managed diabetics who may never heal and will eventually require a below-the-knee amputation. It is therefore common for surgeons to restrict walking and other activities that could stress the wound and delay healing.

The FibuLock nail is designed to treat the same fractures as plates as well as provide for anatomic ligament stabilization, but with a much less-invasive approach, according to the company.

The device is implanted into the fibula through a small incision less than an inch long. Reduced incisions are generally recognized to be less susceptible to infection. After the surgeon aligns the broken bones, the nail is inserted within the bone canals. Anchors are then activated, stabilizing the fracture for healing. Additionally, the device is anticipated to lessen the incidence of secondary removal surgeries because FibuLock is inside the bone, which does not create the discomfort associated with plates.

Sonoma plans to introduce the FibuLock into “select geographies” in the second quarter of 2015. The company did not outline which areas would be included in the initial release.

“I have been using intramedullary devices for 20 years to repair ankle fractures due to their capacity to avoid wound issues and expedite patient rehabilitation,” said Robert Tonks, M.D., an orthopedic surgeon from San Diego, California. “However, these devices are basically metal rods with screws at their lower end to stabilize fractures. Half of fractures are above these screws, and the rods are not applicable. Furthermore, these rods have simplistic surgical instruments that make it difficult to align a fracture compared to a plate. The FibuLock nail features internal bone anchors, which allow alignment and support of any operable fracture including higher fibula fractures. In addition, the instruments are expressly designed to anatomically realign the bones.”

Rick Epstein, CEO of Sonoma said: “Nails have already replaced plates as the gold standard for repairing fractures in the femur and tibia—thigh and shin bones—because nails are less invasive and deliver fewer post-operative complications with faster rehabilitation. However, developing a nail for the fibula is difficult due to its small size and unique geometry. Until the FibuLock, there wasn’t a device that could deliver the stability, versatility and effectiveness of plates. Now, our technology will allow surgeons to bring the advantages of nailing to ankle fracture patients.”