FDA clears Orthofix Fitbone transport and lengthening system

Orthofix (Nasdaq: OFIX) today announced it received FDA 510(k) clearance for the Fitbone Transport and Lengthening […]

Orthofix (Nasdaq: OFIX) today announced it received FDA 510(k) clearance for the Fitbone Transport and Lengthening System and reported the first implant of the device.

The Lewisville, Texas-based company designed Fitbone to treat large bone defects in the femur and tibia caused by trauma, infectious, or malignant conditions.

“Patients with defects to the femur and tibia can be difficult to treat and often have undergone multiple prior surgeries,” said Dr. David Frumberg, an orthopedic surgeon and Director of the Limb Restoration and Lengthening Program in New Haven, Connecticut, who performed the first U.S. implantation. “The Fitbone Transport and Lengthening System is a game-changing new option that enables bone to be transported across the defect, allowing very challenging problems to be treated without multiple follow-up surgeries.”

Fitbone has the same motorized technology that is in the Fitbone TAA Intramedullary Lengthening System. It is implanted through a minimally invasive procedure and contains the motorized intramedullary nail, a receiver and an external control set that allows a patient to manage the distraction phase at home. The nail and receiver are removed once the treatment is complete.

“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,” CEO and President Massimo Calafiore said in a news release. “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.”

Original article (https://www.massdevice.com/fda-clears-orthofix-fitbone-transport-and-lengthening-system/)