WAYNE, Pa., Aug. 15, 2017 /PRNewswire/ -- Camber Spine
Technologies announced today that it has received 510(k) clearance
from the U.S. Food and Drug Administration (FDA) to market its
SPIRA™ Open Matrix ALIF device, a unique, interbody fusion implant
consisting of spiral support arches and Surface by Design™
technology. This clearance marks Camber's tenth line of
spinal implant systems to be released in the US market.
SPIRA™ was designed specifically to increase fusion rates and
stabilization. The spiral support arches decrease subsidence by
load sharing over the entire endplate, while also maximizing bone
graft capacity. The Surface by Design™ technology is a deliberately
designed roughened surface that facilitates bone growth through an
optimized pore diameter, strut thickness and trabecular
pattern.
The Camber Spine SPIRA™ Open Matrix ALIF is indicated for use in
skeletally mature patients with Degenerative Disc Disease (DDD) at
one or two contiguous levels from L2-S1. SPIRA™ Open Matrix ALIF is
intended to be used with additional FDA-cleared supplementary
fixation systems.
"Camber Spine is very excited to be launching our first in a
series of spinal implants using 3D printed - additive
manufacturing. This specialized manufacturing technology allows us
to create these truly unique patented structures featuring open
arched matrixes and proprietary surfaces designed to enhance fusion
and promote bone growth. In the coming months we will be launching
a series of five SPIRA™ spinal inter-body cages for
cervical, lateral, and posterior lumber spine. Extremity implants
and custom implants for salvage and complex deformity implants are
also under development."
"We believe that the addition of SPIRA™ and
ENZA™ MIS Integrated inter-body devices to our product
portfolio create a foundation of patented implant solutions that
will drive the growth of Camber Spine."
-Daniel Pontecorvo, CEO Camber
Spine
The Camber Spine SPIRA™ Open Matrix ALIF is indicated for use in
skeletally mature patients with Degenerative Disc Disease (DDD) at
one or two contiguous levels from L2-S1. SPIRA™ Open Matrix ALIF is
intended to be used with additional FDA-cleared supplementary
About Camber Spine
Camber Spine Technologies, LLP, is a medical device company
focused on the design, development and commercialization of
innovative and proprietary musculoskeletal implant systems. The
company is committed to delivering surgeon inspired new
technologies to the spine market. Camber Spine, located in
Wayne, Pennsylvania, markets a
line of proprietary musculoskeletal products nationwide through its
exclusive distributor, S1 Spine.
All of Camber Spine's products are proudly MADE IN THE
USA.
If you would like more information about this topic, please
contact Mindy Elgart, Marketing
Director at 484.420.4671 or email at melgart@cambermedtech.com
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SOURCE Camber Spine Technologies