Orthofix Announces US and European Full Market Launch of FITBONE Limb-Lengthening System

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Orthofix Medical Inc, a global medical device company with a spine and extremities focus, announced the U.S. and European full market launch of the FITBONE® intramedullary lengthening system for limb lengthening and deformity correction of the femur and tibia bones.

“Orthofix is the only orthopedic company that offers a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction and deformity correction,” said Orthofix President of Global Extremities Paul Gonsalves. “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.”

The FITBONE intramedullary lengthening nail is a fully implantable system for correcting leg length and deformity discrepancies. Implanted through a minimally invasive procedure, the system consists of the implanted intramedullary nail, a subcutaneously implanted receiver and an external control set that enables the patient to manage the distraction phase at home.

The system is designed to provide accurate and controlled limb lengthening, with more than 3,500 cases performed in 15 countries since its development. With appropriate preoperative planning, it allows achievement of axial and torsional bone alignment intraoperatively, as part of the limb-lengthening procedure.

The FITBONE intramedullary lengthening system is available in the U.S. under a U.S. Food and Drug Administration 510(k) clearance and in European Countries under a CE Mark approval.

The system is a part of the Orthofix Extremities portfolio of solutions that include 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 the eight-Plate Guided Growth System™ for correcting angular growth deformities in pediatric patients.

About Orthofix

Orthofix Medical Inc. is a global medical device and biologics company with a spine and extremities focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patients’ lives. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in more than 70 countries via the Company’s sales representatives and distributors.