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 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.”

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