LEWISVILLE, Texas– Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced Fitbone™ TAA intramedullary limb-lengthening system has passed 5,000 devices implanted to date with more than 20 years of clinical history demonstrating safety and effectiveness in limb lengthening and deformity correction in adults and children.
“The ability to extend the femur or tibia bone with an internal motorized lengthening nail is an important treatment option for patients who suffer from limb length discrepancies,” said Professor Franck Accadbled, an orthopedic surgeon with the Department of Orthopaedic Surgery, CHU de Toulouse, Hospital des Enfants in Toulouse, France. “Clinical studies and the robust history of the Fitbone intramedullary system reinforce what we have seen in our extensive use of the device, giving us confidence it is a safe, viable option for lower limb lengthening.”
The Fitbone intramedullary lengthening nail, acquired from Wittenstein SE in March 2020, is a fully implantable system for correcting leg length and deformity discrepancies. Implanted through a minimally invasive procedure, the system consists of the motorized intramedullary nail, a subcutaneously placed 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.
“Clinical experience and published, peer-reviewed data for the Fitbone intramedullary limb-lengthening system continue to reinforce the safety and efficacy of this life-changing technology,” said Kim Elting, Orthofix President of Global Orthopedics. “We are the only company to offer a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction and deformity correction, and Fitbone is a key technology platform we intend to continue to build on to offer surgeons the best internal solutions for their patients.”
The Fitbone intramedullary lengthening system is available in the U.S. under a U.S. Food and Drug Administration 510(k) clearance and is the only lengthening nail with a pediatric indication. The system is also available in European and other countries under a CE Mark approval.
