Spinal Simplicity announced the FDA 510(k) clearance of its
Patriot-SI Posterior Implant System, designed for sacroiliac joint
fusion in combination with the Liberty-SI lateral system. This
clearance introduces a hybrid SI joint fusion construct, offering
new treatment options for conditions such as sacroiliac disruptions
and degenerative sacroiliitis.
OVERLAND
PARK, Kan., May 1, 2024
/PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to
announce the Food and Drug Administration (FDA) 510(k) clearance of
the Patriot-SI Posterior Implant System as part of a hybrid SI
joint fusion construct to be used in conjunction with the
Liberty-SI lateral transfixing system. The Patriot-SI Posterior
Implant System is intended for sacroiliac joint fusion for
conditions including sacroiliac disruptions and degenerative
sacroiliitis. When the Patriot-SI System (i.e., an "in-line" or
"intra-articular" device) is implanted, it must be used with a
Spinal Simplicity Liberty-SI Lateral System device (i.e., a
"transfixing" device) implanted across the same sacroiliac joint to
create a hybrid SI joint fusion construct.
"The Patriot SI technology is constructed
intentionally as a cannulated implant, designed for repeatable,
reproducible techniques, with the implant traveling directly over
the guidewire for precision placement in the SI Joint," said CEO
Todd Moseley.
"This announcement today marks a second product milestone in the
past five months for Spinal Simplicity," said CEO Todd Moseley. "We've already seen excellent
patient outcomes with the Liberty-SI Lateral System since its
introduction in December 2023. The
Patriot SI technology is constructed intentionally as a cannulated
implant, designed for repeatable, reproducible techniques, with the
implant traveling directly over the guidewire for precision
placement in the SI Joint," added CEO Todd
Moseley.
Spinal Simplicity has been granted patent protection for the
novel Patriot-SI cannulated and threaded device, which includes an
internal lattice structure to promote fusion. The patented
cannulated design is the only posterior SI device that allows
continuous control while being delivered over a guidewire.
"Today marks a milestone for my patients who are hypermobile and
may need an advanced construct in their SI Joint along all planes
of the joint," said Dr. Dan Kloster
of Crimson Pain Management in Overland
Park, KS. "I now have this option in my toolkit for the
right patient to help alleviate their SI Joint pain."
The Patriot-SI is a minimally invasive SI joint fusion implant
intended for implantation on a trajectory in line with the joint
space. The additively manufactured titanium implant is available in
one size, fixating both the sacrum and ilium via external threads.
The procedure also involves the lateral insertion of a small
titanium Liberty-SI implant, transfixing the SI joint to stabilize
and fuse the joint. This hybrid surgical technique ensures robust
decortication of the bone to prepare the joint for fusion.
"The FDA clearance of the Patriot-SI posterior system, to be
implanted with the Liberty-SI lateral system as a hybrid construct,
gives us as physicians another option for our patients based on
their underlying cause of SI discomfort," said Dr. Doug Beall of Oklahoma
City, OK. "Spinal Simplicity continues to innovate and is
not content with the status quo. This approach certainly helps our
patients who are struggling with SI Joint pain and dysfunction."
Patriot-SI's anticipated soft market launch is scheduled for late
Q2 of 2024, with a full market release in Q3 of 2024.
For further information or media inquiries, please contact
Parker Snedden, Senior Director of
Marketing, at psnedden@spinalsimplicity.com.
About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, Kansas, was founded in 2008
with a vision to be the global leader in innovation, simplified
surgical solutions, delivering uncompromising quality. The company
has successfully been awarded 150+ patents with additional patent
applications pending. For more information visit
spinalsimplicity.com or follow us on LinkedIn.
Media Contact
Parker Snedden, Spinal
Simplicity, 1 (913) 451-4414, psnedden@spinalsimplicity.com,
https://spinalsimplicity.com
View original content to download
multimedia:https://www.prweb.com/releases/spinal-simplicity-announces-fda-510k-clearance-of-its-sacroiliac-joint-system-the-patriot-si-posterior-implant-with-a-unique-hybrid-indication-for-use-302133472.html
SOURCE Spinal Simplicity