CTL Medical has recently secured clearance from the US Food and Drug Administration (FDA) to market its new Seurat Universal pedicle screw system for the practice of spinal fusion surgery.
This is the second FDA clearance for the company in the first quarter of 2018. CTL Medical’s in-house research and development team designed the Seurat Universal pedicle screw system after working closely with surgeons to determine the most comprehensive, adaptable, and advanced features for use in the surgical operative environment, the company claims.
Danny Chon, CTL Medical CEO, states, “The FDA approval of the Seurat Universal pedicle screw system enables us to offer very versatile intraoperative hardware options for surgeons and the surgical spine industry as a whole.”
The Seurat Universal pedicle screws are medically classified as bone screws, designed for direct implantation into a vertebral pedicle. The company press release states, “This system is a compilation and consolidation of the best features from each of CTL Medical’s already cleared pedicle screw systems, boasting the addition of true intraoperative versatility.” The system has a modular housing assembly option, as well as the option to select a standard or reinforced-ring locking set screw. The system includes polyaxial and monoaxial; open and MIS; single and dual thread profile; solid and cannulated; and hex and hexalobe screws of all diameters and lengths.
CTL Medical expects to launch the Seurat Universal pedicle screw system in the second half of 2018.