Orthofix Medical announced the FDA 510(k) clearance and first U.S. implant of the Fitbone Transport and Lengthening System. Used to treat large bone defects in the femur and tibia due to trauma, infectious or malignant conditions, the device is the only intramedullary nail designed to transport or lengthen the bone through a single surgery.
The system features the same motorized technology found in the Fitbone TAA Intramedullary Lengthening System, a product that has been in clinical use for more than 20 years and is supported by numerous publications. Implanted through a minimally invasive procedure, the system consists of the motorized intramedullary nail, a receiver and an external control set that enables the patient to manage the distraction phase at home. Once the treatment is complete, the nail and receiver are removed.
“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,” said Massimo Calafiore, Orthofix President and CEO. “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.”
Orthofix Medical announced the FDA 510(k) clearance and first U.S. implant of the Fitbone Transport and Lengthening System. Used to treat large bone defects in the femur and tibia due to trauma, infectious or malignant conditions, the device is the only intramedullary nail designed to transport or lengthen the bone through a single surgery. ...
Orthofix Medical announced the FDA 510(k) clearance and first U.S. implant of the Fitbone Transport and Lengthening System. Used to treat large bone defects in the femur and tibia due to trauma, infectious or malignant conditions, the device is the only intramedullary nail designed to transport or lengthen the bone through a single surgery.
The system features the same motorized technology found in the Fitbone TAA Intramedullary Lengthening System, a product that has been in clinical use for more than 20 years and is supported by numerous publications. Implanted through a minimally invasive procedure, the system consists of the motorized intramedullary nail, a receiver and an external control set that enables the patient to manage the distraction phase at home. Once the treatment is complete, the nail and receiver are removed.
“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,” said Massimo Calafiore, Orthofix President and CEO. “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.”
Copy to clipboard 
