KING OF PRUSSIA, PA — Camber Spine has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SPIRA-A Integrated technology. This development marks a significant milestone for the company’s innovative SPIRA product platform.
The SPIRA-A Integrated Fixation System is an anterior lumbar interbody fusion (ALIF) device designed with an open matrix to allow for the packing of graft material, which facilitates fusion. It also includes additional fixation options to secure the implant within 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 Brooks McAdam, CEO of Camber Spine. “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.”
SPIRA-A Integrated offers a comprehensive solution for the ALIF procedure. It includes integrated fixation, a windswept cage geometry for accessing L5-S1, and up to 40 points of endplate contact per implant. The device’s superior and inferior surfaces are rough to prevent movement during fusion, and it features structural arches to distribute load across the joint space.
The device also includes three holes for inserting bone screws or anchors, along with blocking screws to prevent fixation back-out. These screws and anchors are designed to complement the cage’s performance, increasing fixation in the cortical endplate and featuring a SPIRA Surface to enhance osseointegration and resist pull-out.
The FDA’s clearance indicates that the SPIRA-A Integrated system can be used for one or more levels from L1-S1. It is suitable for skeletally mature patients with conditions including degenerative disc disease, disc herniation, spondylolisthesis, deformity, spinal stenosis, and failed previous fusion.
Camber’s SPIRA implants are 3D printed, allowing the company to create unique patented structures with open arched matrices and proprietary surfaces that promote bone growth and enhance fusion. All of Camber Spine’s products are developed and manufactured in the United States.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.