Healthcare Industry News:  intervertebral body fusion 

Devices Neurosurgery Orthopaedic FDA

 News Release - November 20, 2007

Spinal Elements, Inc. Receives FDA 510(k) Market Clearance for its Lucent(R) Spinal Implants as a Lumbar Intervertebral Body Fusion Device (IBFD)

CARLSBAD, Calif.--(HSMN NewsFeed)--Spinal Elements, Inc. announced today the receipt of FDA 510(k) clearance to market the Lucent® Spinal Implants as lumbar intervertebral body fusion devices (IBFD). This clearance of the Lucent system enables surgeons to utilize this advanced implant and instrumentation technology for degenerative disc disease and other common spinal maladies.

Lucent IBFD implants are manufactured from radiolucent PEEK-OPTIMA® polymer, allowing the surgeon to better view the fusion site under X-ray. The Lucent IBFD system is suitable for direct posterior and transforaminal approaches to the lumbar disc space. Lucent direct posterior implants are available in 10mm and 8mm widths from 7mm thru 14mm heights in one-millimeter increments with convex-parallel and convex-lordose options. Lucent transforaminal implants are 10mm wide and available in sizes ranging from 8mm thru 14mm in one-millimeter increments. All Lucent implants include patented graft space features along with a tapered bullet nose, designed to enable easy insertion. The Lucent IBFD instrumentation is a robust color-coded system designed to enable quicker and safer interbody fusion procedures.

“This 510(k) is among the first cleared by the FDA for this indication. This is a strong sign of the regulatory and product development capabilities of Spinal Elements,” said Spinal Elements CEO, Todd Andres. “Spinal Elements is committed to continually expanding and improving our world-class spinal fusion products while developing advanced motion preservation technologies that expand the spine market by providing additional options for patients and surgeons alike.”

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 arthroplasty device designed to relieve facet joint pain. The worldwide spinal instrumentation market is currently valued at over $5 billion and growing.

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


Source: Spinal Elements

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