Orthofix Receives FDA’s 510(k) Clearance for its TrueLok EVO Ring Fixation System

Orthofix Medical has been granted the FDA’s 510(k) clearance for its TrueLok EVO ring fixation system (EVO is short for “evolution”).

The external fixation device for the lower leg and foot is for use in complex limb reconstruction and deformity correction procedures, according to the Lewisville, Tex.-based company.

The device, which features radiolucent rings and struts for clear radiographic visualization, is intended to let physicians better assess bone anatomy during surgery and postoperative care.

TrueLok EVO is available as a preassembled frame in ready-to-use, single-use sterile packaging, which makes application easier, potentially saving time during surgery, the company said.