Orthofix has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Fitbone transport and lengthening system. The first U.S. implant of Fitbone was also completed.
Fitbone treats femur and tibia defects due to trauma, infectious, or malignant conditions. It’s touted as the only intramedullary (IM) nail to transport or lengthen the bone through a single surgery.
The transport and lengthening system has the same motorized technology in Orthofix’s Fitbone TAA IM lengthening system, which has been in clinical use for over two decades. It’s implanted in a minimally invasive surgery and the system consists of the motorized IM nail, a receiver, and an external control set so the distraction phase can be managed at home.
Once the treatment is done, the nail and receiver are removed.
“The Fitbone Transport and Lengthening System further demonstrates our commitment to expanding surgical options for hard-to-treat conditions, specifically within trauma, that can have a big impact on a patient’s quality of life,” said Massimo Calafiore, Orthofix president and CEO. “We are proud of this milestone achievement and our continued innovation and advancement of the Fitbone product family that has already transformed the lives of so many patients.”
Earlier this year, the company earned FDA 510(k) clearance for the Rodeo telescopic nail, which surgically treats deformities or fractures in patients with osteogenesis imperfecta (OI), also known as brittle bone disease.