Orthofix has received FDA 510(k) clearance and the European CE Mark for the TrueLok Elevate Transverse Bone Transport (TBT) System.
TrueLok Elevate provides a limb preservation treatment option for addressing bony or soft tissue deformities and defects such as diabetic foot ulcers and non-healing or deep tissue wounds. While the TBT procedure has previously been reported, TrueLok Elevate is the first dedicated system for TBT to receive FDA clearance. The product is currently available in a limited market release in the U.S. and select international markets.
“The introduction of the TrueLok Elevate system is a pivotal milestone in demonstrating our commitment to leading growth in the limb reconstruction market,” said Patrick Fisher, President of Global Orthopedics for Orthofix. “Within our orthopedics business, we are focusing on providing innovative solutions that spans four pillars: Limb Preservation, Extremity Deformity Correction, Limb Lengthening, and Complex Fracture Management to aid surgeons in managing patients with complex limb reconstruction needs.”
