Trax Surgical, a company specialized in product development and distribution for the orthopedic extremities market, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its LINKT compression staple system.

LINKT provides a range of nitinol staples for fracture repair, joint fusion and osteotomy procedures. The  nitinol staple with inherent compressive properties creates a stable environment to promote bone healing, the company said.

Trax touts LINKT as an improvement over outdated designs that don’t have the ability to adjust the staple before implantation. It features an adjustable inserter so the staple’s legs can be opened and closed for easy insertion. Multiple staples can be deployed with a correctly sized inserter, which is used to properly seat the implant or to remove and reposition it.

The staples have a slightly curved bridge engineered for even more compression at the fusion site and feature toothed legs for secure fixation. The system is composed of staples sold individually in sterile packaging, and sterile deployment kits comprised of a drill guide, locating pins, and inserter.

“We are incredibly excited about this advancement,” said Shane Shankle, president of Trax Surgical. “The approval of our Nitinol Compression Staple enables us to better serve our customers and elevate the standard of care in extremity orthopedics. It reflects our dedication to innovation, quality, and the needs of both surgeons and patients.”