Orthofix's Fitbone transport and lengthening system earned FDA 510(k) clearance and was used in its first U.S. case., the devicemaker said July 9.
David Frumberg, MD, performed the first U.S. case, according to a news release. The Fitbone system is implanted through a minimally invasive procedure and consists of a motorized intramedullary nail, a receiver and an external control set for patients to manage at home.
The system is used to treat large bone defects in the femur and tibia and is designed to transport or lengthen the bone through one surgery.