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Devices Orthopaedic Neurosurgery FDA

 News Release - February 5, 2007

Life Spine Announces FDA Approval of Pilot(R) Rod System

Versatile new rod and post pedicle screw system allows quick one step lockup

HOFFMAN ESTATES, Ill., Feb. 5 (HSMN NewsFeed) -- Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to Pilot®, a versatile new rod and post pedicle screw system allowing for quick one step lockup.

Using a unique open and MIS cannulated screw design, the surgeon is able to self-guide, self-tap, and self-drill the screws, eliminating time consuming steps from the procedure. The Pilot system is top-loading, and can be quickly and easily assembled outside the body, and then placed in-situ via the all-in- one drill guides. The system can be locked up inline, allowing for an open or an MIS approach. In-situ compression and distraction can be done directly with the bone screw drill guides. The Pilot screws are offered in multiple sizes and combinations.

Patrick J. Sweeney, M.D., a spine surgeon based in Olympia Fields, IL, said that Pilot's innovative design will provide significant benefit to surgical patients, as well as the surgeons performing their spine operations. "By increasing precision and decreasing operating times, patients will have improved outcomes and surgeons should experience lower operative workload," Sweeney said. "The availability of a rod and plate system that Pilot offers gives the surgeon increased flexibility in surgical decision-making."

Life Spine currently markets six different product lines including Pilot® Posterior Plate, Kinetic® Dynamic Cervical Plate, Arx® Polyaxial Pedicle Screw System, and Plateau(TM) series spacers manufactured from Invibio® PEEK OPTIMA® polymer.

For more information, please visit .

Source: Life Spine

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