Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Cannulated Screw Internal Fixation System. This clearance further expands the offering of Cannulated Screws for Centric Medical, to be used in Foot & Ankle reconstruction procedures.
"I am excited to add another cannulated screw option to our rapidly growing foot and ankle portfolio. This addition has allowed for a more robust offering for distal extremity procedures including reconstruction, joint fusion, osteotomies, fracture repair, arthrodesis and fracture fixation," said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. "The system is extremely easy to use, low profile and offers partially and fully threaded options. I am incredibly proud that Centric Medical saw five 510K clearances in 2017 and I think a full cannulated screw selection is an integral step to a complete foot and ankle portfolio."
The Cannulated Screw Internal Fixation System is a streamlined multi-component system comprised of titanium alloy, with a wide variety of diameters and lengths. The new options, which are specifically indicated for the forefoot, come in 2.0, 2.5, and 3.0mm diameters with headed and headless designs. This system complements the previously FDA cleared range of 3.5-7.5mm diameters indicated for the midfoot and hindfoot which also offer designs with and without a head.