Healthcare Industry News:  cervical spine 

Devices Orthopaedic Neurosurgery FDA

 News Release - October 25, 2007

Spinal Elements, Inc. Receives FDA 510(k) Market Clearance for its Mosaic(TM) Spinal System as a Cervical Intervertebral Body Fusion Device (IBFD)

AUSTIN, Texas--(HSMN NewsFeed)--Spinal Elements, Inc. announced today at the National Association of Spine Surgeons (NASS) 2007 annual meeting the receipt of 510(k) clearance to market the Mosaic™ Spinal System as a cervical Intervertebral Body Fusion Device (IFD). The Mosaic Spinal System is the only implant of its kind marketed in the US. Mosaic is a cervical IBFD coupled with an anterior plate to allow superior and inferior screw fixation and is available in 2, 3, and 4-screw configurations.

The Mosaic Spinal System is manufactured from radiolucent PEEK-OPTIMA® polymer, allowing the surgeon to better view the fusion site under X-ray. Conventional titanium metal cervical plates tend to obscure X-ray visualization of the fusion site particularly in anterior-posterior (front to back) films. In addition, the various configurations of the Mosaic system implants allow surgeons to address a variety of anatomies and surgical conditions. Because Mosaic is a combination device, combining intervertebral body support and anterior fixation, surgery time is typically reduced with surgeons trained on implanting with Mosaic™ devices. Mosaic is accompanied by a color-coded instrumentation system designed to safely and easily implant the product.

“The Mosaic Cervical Fusion System is a leap forward in technology for cervical fusion procedures,” said Todd Andres, president and CEO of Spinal Elements. “The additional IBFD indication for Mosaic’s use will enable surgeons to further utilize Mosaic’s advanced technology, offering greater versatility and allowing superior fusion site viewing during X-Ray. The technology improvements Mosaic offers are sufficient justification for this technology to become the standard of care for cervical spine fusion.”

Spinal Elements, headquartered in Carlsbad, Calif., is a spine technology company offering unique spinal implant technologies that are marketed throughout the US. Spinal Elements is focused on developing innovative fusion and spine motion preservation technologies. Spinal Elements is developing the Zyre™ facet augmentation device designed to relieve facet joint pain. The worldwide spinal instrumentation market is currently valued at over $5 billion and growing at a rate in excess of 20% annually.

Additional information is available on the company website at www.spinalelements.com.


Source: Spinal Elements

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