Camber Spine Receives FDA Clearance for SPIRA-A Integrated Fixation System
23 Julio 2024 - 10:31AM
Business Wire
Camber Spine, a leading innovator in spine and medical
technologies, announced today that it has received U.S. Food and
Drug Administration (FDA) 510(k) clearance for its SPIRA-A
Integrated technology.
Part of the SPIRA product platform, the SPIRA-A Integrated
Fixation System is an anterior lumbar interbody fusion device that
has an open matrix design to permit packing with autogenous and/or
allogenous graft material to facilitate fusion, as well as
additional fixation options to secure the implant in the disc
space.
“The FDA’s 510(k) clearance of our SPIRA-A Integrated technology
ushers in the next evolution in our innovative SPIRA platform and
marks another major step forward in our company’s development,”
said Camber Spine CEO Brooks McAdam. “It also helps bring more
innovation-based solutions and options to the surgical community
and a solution for surgeons engaging or wanting to engage in the
ALIF market. We believe SPIRA Technology, which encompasses the
structure, surface, and science behind our 3D-printing process, is
the archetypal design for modern spine implants and exemplifies the
true benefits of additive manufacturing.”
SPIRA-A Integrated offers a complete solution to the ALIF
procedure, with integrated fixation deployed in a traditional ALIF
cage and approach, as well as a windswept cage geometry for
accessing L5-S1 with difficult vascular anatomy, and each implant
offers up to 40 points of endplate contact.
The superior and inferior surfaces of the SPIRA-A Integrated
device have a rough surface to help prevent movement of the device
while fusion takes place, and structural arches to help distribute
load across the joint space. The device contains three holes to
insert bone screws or anchors for integrated fixation, as well as
blocking screws to prevent fixation back-out.
SPIRA-A’s screws and anchors have been designed to complement
the performance of the cage, increase fixation in the cortical
endplate, and provide first-of-their-kind 3D-printed anchors with a
SPIRA Surface, designed to increase potential for osseointegration
and resist pull-out.
The robust inserter attachment, multiple technique
possibilities, and a wide variety of screw prep options are
designed to facilitate clear visualization of, and easy access to,
the surgical site once the approach is complete.
The FDA’s action means that SPIRA-A Integrated is now indicated
for use at one or more levels, from L1-S1 as an adjunct to fusion
in skeletally mature patients with degenerative disc disease (DDD),
disc herniation (with myelopathy and/or radiculopathy)
spondylolisthesis, deformity (degenerative scoliosis or kyphosis),
spinal stenosis and failed previous fusion (pseudarthrosis).
Camber’s SPIRA implants are 3D printed. This specialized
manufacturing technology allows Camber to create unique patented
structures featuring open arched matrices and proprietary surfaces
designed to enhance fusion and promote bone growth.
All of Camber Spine’s products are developed and manufactured in
the United States.
Innovative spine and medical technology company Camber Spine
Technologies is dedicated to creating surgeon-designed solutions in
MIS and minimally disruptive access for the treatment of complex
spinal pathology. Incorporating state-of-the-art manufacturing, 3-D
printing, and an acute sensitivity to patient anatomy, Camber Spine
is making quantum leaps in the spinal fusion market. Learn more at
CamberMedtech.com.
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Paul Williams, 310-569-0023,
paul@medialinecommunications.com