510K Clearance For Custom Spine’s Securis Cannulated Screw System

In short

Custom Spine has announced the 510K Clearance of the Securis cannulated pedicle screw system. This system marks Custom Spine’s entry into the minimally invasive spine market and will be available for demonstration at the annual meeting of the American Association of Neurological Surgeons being held right now, April 14 – 18, in Miami Beach.

Background

In February we covered the announcement that Custom Spine’s broad portfolio of spinal implants that were at the time marketed in USA. Now they can add another to the US list with the FDA approval of the Securis, cannulated pedicle screw system.

Custom Spine’s objective was to develop a minimally invasive system that enhances screw placement and the ability to fully seat the screw under limited visual assessment. The design of Securis helps screw placement and provides a screw that can be fully seated in the bone while maintaining full polyaxial motion of the screw head for easier rod insertion.

According to a company press release, data shows that a fully seated screw can withstand 63% greater shear force than traditional unseated screws, decreasing the chance for screw loosening and creating a stronger biomechanical construct. Securis provides surgeons with a cannulated bone screw that takes advantage of the benefits of fully seated screws.

The Securis cannulated screw system features a chromium-cobalt rod which provides superior stiffness when compared to a titanium rod of the same diameter. The superior stiffness in a smaller rod allows for a lower profile construct without sacrificing strength. In addition, Custom Spine has provided advanced instrumentation for easier implantation while allowing the surgeon greater control of implant placement.

Company comments

“Custom Spine is excited about this upcoming release of the first of many minimally invasive solutions for spine surgeons,” commented Mahmoud Abdelgany, President of Custom Spine. “The FDA clearance of Securis represents the successful completion of another milestone for the company and supports our future growth plans.”

Source: Custom Spine Inc, PR Newswire