US-based spine and orthopaedics company Orthofix Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its Fitbone transport and lengthening system.
Orthofix also announced that the first US implant of its orthopaedic device was performed by Limb Restoration and Lengthening Program director, orthopaedic surgeon David Frumberg.
Fitbone is an intramedullary limb-lengthening system designed to treat large bone defects in the femur and tibia due to trauma, or infectious or malignant conditions.
It is the only intramedullary nail designed to transport or lengthen the bone through a single surgery, said the spine and orthopaedics company.
Frumberg said: “Patients with defects to the femur and tibia can be difficult to treat and often have undergone multiple prior surgeries.
“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.”
The Fitbone transport and lengthening system features the same motorised technology as the Fitbone TAA Intramedullary Lengthening System, which has been available for 20 years.
It is implanted through a minimally invasive procedure and contains a motorised intramedullary nail, a receiver, and an external control set.
The system enables the patient to manage the distraction phase at home, and the nail and its receiver are removed once the treatment is complete.
The medical device company has started commercialising its Fitbone transport and lengthening system in the US, under a limited market release.
Orthofix president and CEO Massimo Calafiore said: “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.
“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.”
