Devices Orthopaedic Neurosurgery FDA

 News Release - April 12, 2012

Custom Spine Announces 510(k) Clearance for Securis Cannulated Screw System

PARSIPPANY, N.J., April 12, 2012 -- (Healthcare Sales & Marketing Network) -- Custom Spine announced today the 510(k) 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 next week, April 14 – 18, in Miami Beach.

The objective, working in close collaboration with key surgeon leaders, 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. 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.

"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."

About Custom Spine

Custom Spine, Inc. is a pioneering leader in the spine market creating the next generation of surgeon-friendly spinal implants and instruments that provide superior performance and patient care. The company was founded by top engineers and industry professionals in partnership with orthopedic and neurological spine surgeons to develop advanced medical solutions. Custom Spine (www.customspine.com) is a privately held company headquartered in Parsippany, New Jersey. For more information, please contact 1-973-808-0019.

Source: Custom Spine

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