Meditech Spine said today it has received FDA 510(k) clearance to market the CURE Opel-C Plate spinal implant system, an add-on technology to its already cleared CURE anterior cervical plate (ACP) system and Talos-C hydroxyapatite (HA) interbody systems. With this approval, Meditech will now offer two additional CURE ACP plating options with its Talos line of cervical interbodies made with the osteoconductive PEEK-Optima HA-enhanced material. Since Meditech introduced its CURE ACP system in late 2016, its adoption and usage have seen double-digit growth, according to a company statement.

By adding the Opel-C plating options to the CURE ACP product line, surgeons now have two modular snap-on plate styles providing rigid fixation while minimizing adjacent level impact. The CURE Opel-C plate system incorporates the same one-step locking mechanism of the CURE ACP system to prevent screws from backing out when anchored in the vertebral body. Meditech will be demonstrating the newly approved system and the Talos HA PEEK interbody systems at the North American Spine Society meeting in Los Angeles Sept. 26-28. A portion of proceeds from the sale of every plate benefits CURE International, an organization serving children with physical disabilities in underserved areas of the world, the company said.