X-spine Lands FDA Approval for Two New Spinal Systems
11/2/2012 6:38:37 AM
X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, today announced two new USFDA clearances for spinal systems: The Fortex ™ CoCr Rod System and the Certex™ Cervico-thoracic Fixation System.
The clearance of these two systems further advances X-spine’s position as a full-line spinal company, addressing all of the key needs of today’s spine surgeon. The Fortex CoCr system incorporates a new 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 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 stabilization procedures.
“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.”
The Fortex™ CoCr Rod System and the Certex™ Cervico-thoracic Fixation System join X-spine’s continually expanding portfolio of innovative spinal devices, including the AXLE™ Interspinous Fusion System, the Calix™/Calix PC™ Intervertebral Fusion Systems, the FIXCET™ Facet Fixation System, the BUTREX™ Buttress Plating System, the FORTEX™ and X90™ Pedicle Screw Systems, the SPIDER™ Cervical Plating System, and the HGRAFT™ Spinal Allograft System.
Founded in 2003, privately-held X-spine Systems, Inc. (www.x-spine.com) designs and manufactures surgical implants and instrumentation for use in spinal surgery. With facilities in Ohio and the Netherlands, X-spine brings its philosophy of inventive products, simplicity of design, and intuitive function to spine surgeons and patients worldwide.
X-spine Systems, Inc.
Erik Laidhold, VP of Sales, 937-847-8400