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Life Spine Announces FDA Approval Of Kinetic(R)
Life Spine announced
today that the U.S. Food and Drug Administration (FDA) has given 510(k)
marketing clearance to Kinetic(R), 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(R) Posterior Plate
The Pilot(R) 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(R)
Arx(R) 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(R) PEEK
OPTIMA(R) 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
Life Spine
http://www.lifespine.com
Life coloanei vertebrale anunta aprobarea FDA de cineticã (R) - Life Spine Announces FDA Approval Of Kinetic(R) - articole medicale engleza - startsanatate