CTL Wins FDA Clearance for Pedicle Screw

CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has recently secured clearance from the Food and Drug Administration to market its new SEURAT Universal Pedicle Screw System for the practice of spine 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 FDA clearance 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,” stated Danny Chon, CEO for CTL Medical Corporation. “As the general population continues to age and the reported degenerative spine cases increase, it is inevitable that the pedicle screw market and related instrumentation challenges will continue to grow, ultimately demanding a one-stop solution. As an answer to this need, we designed the SEURAT Universal Pedicle Screw System to be a truly comprehensive pedicle screw offering unlike any other in the market today.”
 
The SEURAT Universal Pedicle Screws are medically classified as bone screws, designed for direct implantation into a vertebral pedicle. 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 modular housing assembly option enables surgeons to intraoperatively build the most appropriate implant for the present indication, and the option to select a standard or reinforced-ring locking set screw ensures the SEURAT Universal Pedicle Screw System will accommodate a broader range of anatomical challenges and usage preferences. This comprehensive single 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.