Medical device firm First Ray has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its CortiClamp system for small bone fixation.
CortiClamp is a two-part bone screw system that can be used in fracture fixation, osteotomy and arthrodesis procedures.
Generally, conventional bone screws such as cortical screws, lag screws and headless compression screws will be used to carry out these procedures.
CortiClamp is claimed to be the first bone screw system to include a second screw head, which is attached to the distal end of the screw, offering screw heads on both ends of the screw shaft that create bi-cortical clamping force.
The system also acts as a reduction clamp, drill guide, countersink guide, depth gage and implant delivery guide.
According to the company, CortiClamp eliminates several surgical procedure steps, including placement of provisional fixation.
University of California’s orthopedic surgery clinical professor Dr Michael Coughlin said: "The CortiClamp system will be my preferred fixation system for several of my foot and ankle procedures, including oblique osteotomies for bunion and bunionette procedures.
"The CortiClamp system provides more confidence in the quality of my bone fixation, especially in cases where the bone is more osteopenic or osteoporotic."