Orthofix Medical has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for its Fitbone Transport and Lengthening System.
This medical device is designed to address large bone defects in the femur and tibia resulting from trauma, infection or malignant conditions, through a single surgical procedure.
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Featuring a similar motorised technology used in the Fitbone TAA Intramedullary Lengthening System, the Fitbone system is implanted via a minimally invasive procedure and includes a motorised intramedullary nail, a receiver, and an external control set.
This allows patients to self-manage the bone distraction phase from the comfort of their home.
After treatment completion, the nail and receiver are surgically removed.
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.
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By GlobalData“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.”
The Fitbone Transport and Lengthening System is now available in the US on a limited market release basis.
Limb Restoration and Lengthening Program in New Haven, Connecticut director and orthopaedic surgeon Dr David Frumberg performed the first implantation of the Fitbone system in the US.
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.”
Last year, Orthofix Medical commercially introduced its WaveFormL lateral lumbar interbody system in the US.
