X-spine Signals Intent With Two New FDA Clearances

In short

Spinal device company X-spine Systems Inc. has announced two new U.S. FDA clearances for its products: The Fortex ™ CoCr Rod System and the Certex™ Cervico-thoracic Fixation System.


X-spine’s stated philosophy in designing and manufacturing surgical implants and instrumentation for use in spinal surgery is a combination of inventive products, simplicity of design, and intuitive function.

The newly cleared Fortex CoCr system incorporates a cobalt chromium fixation rod which allows for increased construct strength, stiffness and shape-holding. This provides additional functionality to the current Fortex™ platform of products for the fixation of the thoracic and lumbar spine, particularly in deformity procedures.
The company says its new X-spine Certex™ system expands X-spine’s product offering into the posterior cervical spine, and features a comprehensive platform of implants and instruments for cervical stabilisation procedures.

Company comments

“Both the Fortex™ CoCr and the Certex™ were developed with intensive practitioner input to address the practical needs of spine surgeons and patients worldwide. It is our strategy to be able to address every instrumented spinal pathology and approach with our products, while leading with innovative design and surgical practicality,” states David Kirschman, M.D., President and CEO of X-spine. “These two clearances exemplify this strategy, and represent the beginning of a new product initiative at X-spine which will see five major product introductions in the next year.”

Source: X-Spine Systems Inc.