X-spine wins FDA nod for spinal screw system

May 24, 2010 by MedCity News

X-spine Systems Inc. wins 510(k) clearance from the Food & Drug Administration for its Fixcet spinal facet screw system.

By Mary Vanac

X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to sell its Fixcet spinal facet screw system.

Fixcet is used to stabilize the spine during spinal fusion procedures, such as treatment of degenerative disk disease, the company said in a press release. Facets are the wing-like bones on the backside of spinal vertebrae.

“We are seeing an evolution to smaller spinal fixation procedures, including those being done on a short patient stay basis,” X-spine CEO Dr. David Kirschman said in the release. “Being a minimally invasive facet system, the Fixcet is ideal for such procedures where lumbar fusion needs to be performed with minimal tissue disruption.”

X-spine’s growing portfolio of spinal implant products includes the Spider cervical plating system, the X90 pedicle screw system, the Calix interbody fixation system, and the Butrex buttress plating system.

In March, the Miamisburg, Ohio-based spinal implant and instrument maker agreed to an exclusive license with Gamma Spine to develop and distribute a spinal cage invented by a professor of orthopedic bioengineering at the University of Toledo.

A year ago, a University of Cincinnati consortium that includes X-spine received a $3 million Ohio Third Frontier grant to develop and commercialize a technology that strengthens materials used to make medical devices. The technology — laser shock peening — treats the surface of materials to make them stronger, longer-lived and resistant to cracks.