Healthcare Industry News:  cervical spine 

Devices Orthopaedic Neurosurgery FDA

 News Release - November 28, 2006

Life Spine Announces FDA Approval of Kinetic(R)

Revolutionary new internally dynamized anterior cervical plating system is unique in marketplace

HOFFMAN ESTATES, Ill., Nov. 28 (HSMN NewsFeed) -- Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to Kinetic®, a revolutionary new internally dynamized anterior cervical plating system.

Michael S. Butler, Life Spine's president, CEO and founder, said Kinetic's flexibility of design will allow surgeons another option when performing cervical spine surgery. "This is a unique product that allows surgeons to accommodate the differing needs of an individual patient's anatomy," Butler said. "The surgeon feedback we've had on this product is tremendous."

Kinetic features 2mm of fully adjustable internal dynamization per level and an ultra slim pre-lordosed profile. The dynamic plates range in sizes from 21mm to 111mm; levels 1-5. It has a unique design that allows for generous screw angulation while providing a large graft window, a feature which competitive products do not have. In addition, the bone screws utilized with Kinetic feature the company's patented Secure-Snap(TM) locking mechanism, which produces an audible and tactile "click" when locked. This unique locking mechanism prevents both screw rotation and backout while still allowing for screw angulation.

Life Spine recently received FDA marketing clearance for four other products. They include:

NEO(TM)

NEO(TM) is an anterior cervical plating system that takes design to a new level of simplicity -- allowing for generous screw angulation while providing a large graft window. In addition, the NEO ACPS bone screws utilize the Secure-Snap(TM) locking mechanism.

NEO offers pre-lordosed plates in levels 1 through 5. It is available in sizes ranging from 20 mm to 110mm. The associated bone screws are offered in two diametrical sizes, 4.0mm (standard) and 4.35mm (rescue); they are both self-tapping and self-drilling. Furthermore, in an attempt to arm surgeons with personalized choices, the screws are provided in lengths of 10, 12, 14, 16, and 18mm.

Pilot® Posterior Plate

The Pilot® Posterior Plate offers the same versatility as the Pilot rod- based system with the rigidity and simplicity of a posterior plate.

Utilizing the same open and MIS cannulated screw system as the rod-based Pilot, the surgeon is able to self-guide, self-tap, and self-drill the screws, shaving cumbersome steps from the procedure. The unique Pilot plate screw- locking mechanism allows the posterior plates to simply slide into place over the all-in-one drill guides for quick installation. In-situ compression and distraction can be done directly with the bone screw drill guides. Furthermore, the Pilot Posterior Plate has been engineered with aggressive screw angulation, 20 degrees in all directions, and a low profile of 4.0mm. True to Life Spine's engineering principles, the plate height and screw position can be adjusted on the fly without the need to add or remove washers. The plates and screws are offered in a plurality of sizes and combinations to accommodate difficult cases.

ARX®

Arx® is a top-loading thoracolumbar pedicle screw system offering a massive 80 degrees of screw angulation.

The Arx head design has both a slim shape and low profile while still maintaining extremely high strength characteristics. The head also embodies several novel mechanisms; one that both prevents cap cross threading and another that allows the surgeon to concertedly freeze the screw orientation while compression and distraction are accomplished. The Arx features cannulated MIS self-tapping and self-threading screws that are color coded and available in sizes 4.5mm to 8.5mm in a variety of standard lengths. The ARX system currently accepts 5.5mm rods with 6.35mm forthcoming.

Plateau(TM)

The Plateau(TM) series spacers are manufactured from Invibio® PEEK OPTIMA® polymer. The implants are designed to accommodate a variety of anatomies; utilizing large open graft spaces, aggressive teeth patterns and reinforced instrument geometries for added strength preventing insertion breakage. The Plateau spacers are provided straight and angled (7 degrees) with bulleted tips in both odd and even size configurations.

About Life Spine

Life Spine is a developer, manufacturer and marketer of specialized, proprietary medical devices serving the orthopaedic and neurosurgery communities. This is a unique business concept that allows the world's leading surgeons to utilize Life Spine to customize, design, develop and patent new instrumentation and techniques to achieve better patient outcomes.

The company is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards and the most technologically advanced manufacturing platforms.

Life Spine, which is privately held, is based in Hoffman Estates, Illinois. For more information, please visit http://www.lifespine.com



Source: Life Spine

Issuer of this News Release is solely responsible for its content.
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