NEW TECHNOLOGY UPDATE
Alphatec Receives FDA Clearance for ALIF Device
Alphatec Holdings Inc., parent com- pany of Alphatec Spine, has been granted U.S. Food and Drug Administration 510(k) clearance to market the
Alphatec Solus internal fixation anterior
lumbar interbody fusion (ALIF) device.
The Alphatec Solus ALIF device features two counter-rotating titanium blades,
which are designed to deploy into adjacent
vertebrae on a zero-degree axis, locking
the device in place. This provides four
points of fixation delivered in a single step.
The device, which is patented by Alphatec,
reportedly provides enhanced segmental
stability with a simplified surgical technique, while providing substantial spacing
to insert bone graft to help promote rapid
fusion at the site.
“We are extremely pleased to announce
that the Alphatec Solus ALIF system will
soon be available for commercial release
within the United States,” said Les Cross,
chairman and CEO of Alphatec Spine.“We
launched Alphatec Solus in Europe in Jan-
uary this year and thus far it has been a suc-
cess. Our product development programs
will remain a collaborative effort between
spine surgeons and our internal develop-
ment group to ensure that the latest prod-
uct innovations keep advancing improved
patient care in the operating room.”
According to Millennium Research
Group, a Canadian research group that
gathers data on the medtech industry, the
market for internal fixation ALIF spacer
devices is estimated to be approximately
$129 million in 2013, representing approx-
imately half of the total market for the
ALIF spacer devices.
Carlsbad, Calif.-based Alphatec Spine Inc.
makes products for the treatment of spinal
disorders associated with trauma, congenital
deformities, disease and degeneration.
Stryker Introduces Mandibulo-
Maxillary Fixation System
Kalamazoo, Mich.-based Stryker Corpora-
tion has released the Universal Smartlock
hybrid MMF (mandibulo-maxillary fixation) system worldwide. The device has
been granted 510(k) clearance by the U.S.
Food and Drug Administration and also is
available in international markets where it
has been cleared for sale.
The Smartlock Hybrid MMF Plate. Photo
courtesy of Stryker Corporation.
Inventor Jeffrey R. Marcus, M.D., associate vice chair of surgery at Duke University, in collaboration with Stryker, designed
the system to combine the strength and
rigidity of arch bars with the safety and efficiency of MMF screws.
“The Universal Smartlock hybrid MMF
system is easy to apply, comfortable for the
patients, and can impressively increase a
surgeon’s efficiency,” said Michael D.
Turner, M.D., associate director of oral and
maxillofacial surgery at Beth Israel and Jacobi Medical Center in New York, N. Y.
According to the company, the Smartlock system’s nine potential points of fixation along the plate offers better posterior
fixation and vector control. The screws
have self-drilling locking technology, designed to allow purchase into both the
bone and the plate for additional stability,
and to eliminate the need for interdental
wiring typically required with arch bars.
“The Universal Smartlock hybrid MMF
system is an effective and technically simple process that may change the surgical
management of maxillary and mandibular
fixation for all surgical specialties,”said Jairo
Bastidas, D.M.D., deputy director of oral
Zimmer Updates Spine Implant
and maxillofacial surgery at Montefiore
Medical Center, New York, N. Y.“Closed re-
duction of the jaws can be accomplished
with less exposure risk to the surgeon, de-
creased operative time and excellent skele-
tal stability. The Universal Smartlock hybrid
MMF system is an innovation for the man-
agement of facial trauma.”
Stryker produces a range of medical de-
vices in segments including surgical, neu-
rotechnology, orthopedic and spine.
System, New Instruments Added
Minneapolis, Minn.-based Zimmer Spine
has released the Zimmer DTO 5. 5 system,
an updated version of the company’s original DTO implant that received U.S. Food
and Drug Administration approval in 2007.
New implants and instruments have been
added to the system, which is part of the
Dynesys product family, so that the Dynesys dynamic stabilization system can be
used with the company’s Sequoia pedicle
screw system and Instinct Java spinal fixation system. According to Zimmer, the
DTO 5. 5 system enables clinicians to treat
varying levels of disc degeneration at adjacent levels, integrating fusion and non-fusion treatments through a single construct.
The Dynesys system is a pedicle-screw
fixation system—an implant device consisting of a spacer, cord and pedicle screw.
It offers an approach to stabilization and
mobilization of the spine and pain relief
that relies on flexible materials and is purported to preserve much of the spinal
anatomy. Dynesys can be used in skeletally
mature patients to provide immobilization
and stabilization of spinal segments. It is
used as an adjunct to fusion to treat degenerative slipped discs (spondylolisthesis)
in the thoracic, lumbar or sacral regions
when there is evidence of resulting neuro-logic impairment or in the case of a previous failed fusion (pseudarthrosis).