Life Spine Announces FDA 510(k) Clearance for SI Joint Revision Offering & Additional Claims for the SImpact® Sacroiliac Joi...
September 22 2020 - 10:51AM
Business Wire
Life Spine, a medical device company that designs, develops,
manufactures and markets products for the surgical treatment of
spinal disorders, announced today that it has received clearance
from the U.S. Food & Drug Administration (FDA) to market a SI
revision offering and additional claims for the SImpact Sacroiliac
Joint Fixation System.
The new clearance adds a 14.5mm diameter screw to Life Spine’s
SI fixation portfolio. The new size focuses on filling a missing
gap in the market for revision surgeries. The larger screw joins
the current offering of self-drilling 12mm and 8mm diameter
threaded implants.
"As sacroiliac fusions become more mainstream, revision
surgeries are increasing due to failures of early devices and poor
surgical technique,” said Dr. Ali Mesiwala of the Southern
California Center for Neuroscience and Spine. “Currently revision
strategies for a non-union or malpositioned implant involve removal
of the prior implant, placement of new instrumentation, and
addition of bone graft. A particularly challenging problem with
these cases is how best to fill the void of bone that is left when
the old implant is removed. The large diameter of the SImpact
Revision implant allows one to fill the bone void while supplying
immediate fixation to the site. This unique implant will
self-harvest local bone and can be pre-packed and post-packed with
allograft to aid in fusion, making SImpact the go-to system for any
SI fusion revision."
Additional claims, indications, and length offerings have also
been granted to the SImpact system. The implant is self-harvesting
and can be used prophylactically in long construct cases. All
implants in the system are now offered in overall lengths of 30mm –
110mm in 5mm increments. Lastly, the 8mm diameter lag screws now
include the aggressive self-drilling screw tip geometry that allows
for minimized surgical steps.
“The SImpact system is already a robust offering for SI
fixation. The additions of the revision screw, updated lag screw,
and the new indications are great adjuncts to the portfolio,” said
Dr. Keith Maxwell of Southeastern Sports Medicine and Orthopedics.
“The system provides an innovative answer to long construct
spinopelvic fixation and having implant lengths up to 110mm makes
it an ideal system to be used in trauma cases. I have performed
numerous SI fixation procedures with many different implants and
SImpact is the most appealing system on the market.”
About Life Spine
Life Spine 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 Huntley, Illinois. For
more information, please visit: http://www.lifespine.com and/or
www.sijointfixations.com.
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Mr. Omar Faruqi Chief Financial Officer ofaruqi@lifespine.com
847-884-6117