X-Bolt System Cleared for Femoral Fracture Fixation

The FDA has cleared X-Bolt Orthopaedic’s Pro-X1 nail for fixation of femoral fractures in adults with osteopenia or osteoporosis.

The device features a titanium nail with a “reversibly expanding” bolt instead of a typical lag screw. The expanding bolt “enables stronger anchorage and rotational stability of the femoral head,” the company said.

The orthopedic device is cleared for use in several different kinds of femoral fractures including surgically-created defects such as osteotomies.

The Dublin, Ireland-based company expects to launch the product in the U.S. market by October.