Aesculap Implant Systems received U.S. Food and Drug Administration 510(k) clearance for the the company's Odontoid Fracture Fixation System. The system is intended for fracture fixation of small bones and small bone fragments including odontoid fractures.
"We are really excited about what the Odontoid Fracture Fixation System brings to our product portfolio as it gives us an easy-to-use screw system to treat type II Odontoid fractures," said Ira Benson, vice president of spine marketing for Aesculap Implant Systems.
The system was designed in collaboration with Ron Apfelbaum, M.D., emeritus professor of neurosurgery at the University of Utah Health Sciences Center. The system is composed of screws and instruments. The 4-millimeter cortical screws are either fully threaded or partially threaded. They are offered in various lengths and are non-sterile. The screws are manufactured from titanium alloy, according to the company,
Aesculap Implant Systems is based in Center Valley, Pa., and is a division of Aesculap Inc., a B. Braun company.