The FITBONE is a fully implantable system that helps to correct leg length and deformity discrepancies
Medical devices maker Orthofix Medical has commercially introduced its FITBONE intramedullary lengthening system in the US and European markets.
Part of the Orthofix Extremities portfolio, the FITBONE system has been designed for limb lengthening and deformity correction of the femur and tibia bones.
Orthofix has already secured 510(k) clearance from the US Food and Drug Administration (FDA) and CE mark approval to market the FITBONE system in the US and European countries.
The FITBONE intramedullary lengthening nail is a fully implantable system designed to correct leg length and deformity discrepancies.
Orthofix’s system features the implanted intramedullary nail, subcutaneously implanted receiver and an external control set to help patients manage the distraction phase at home.
Designed to provide precise and controlled limb lengthening, the system has already been used to conduct more than 3,500 cases in 15 countries since its development.
With suitable preoperative planning, the system enables to achieve axial and torsional bone alignment intraoperatively through the limb-lengthening procedure.
Orthofix global extremities president Paul Gonsalves said: “Orthofix is the only orthopedic company that offers a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction and deformity correction.
“We are pleased to now be able to broaden access to the FITBONE system by expanding availability in the U.S. and Europe, giving surgeons a choice in treating patients in need of deformity correction and limb lengthening.”
Orthofix Extremities portfolio consists of the TL-HEX TrueLok Hexapod System computer-assisted ring fixation system for external limb lengthening, JPS JuniOrtho Plating system with the OrthoNext digital surgery planning software and eight-plate Guided Growth System to correct angular growth deformities in paediatric patients.
In October 2020, Orthofix rolled out its new O-GENESIS graft delivery system to deliver allograft, autograft or synthetic bone graft to orthopedic surgical sites.