Camber Spine, a spine and medical device specialist, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SPIRA-A Integrated technology. The company also utilizes 3D printing.
The top and bottom surfaces of the SPIRA-A Integrated implant are rough to prevent movement of the device during fusion and feature structural arches to help distribute load across the joint space. The device contains three holes for inserting bone screws or anchors for integrated fixation, as well as locking screws to prevent fixation retraction.
“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.”
The SPIRA-A system screws and anchors are designed to complement the performance of the cage, increase fixation in the cortical bone and are the first of their kind to offer 3D printed anchors with a special SPIRA surface designed to promote osseointegration and resist pull-out. The robust insertion guide, multiple technique options and a wide selection of screw preparations facilitate clear visualization and easy access to the surgical site.
FDA clearance 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, spondylolisthesis, deformities such as degenerative scoliosis or kyphosis, spinal stenosis and failed prior fusion (pseudarthrosis).
Camber’s SPIRA implants are manufactured using 3D printing. This specialized manufacturing technology allows Camber to create unique patented structures with open arch matrices and proprietary surfaces designed to enhance fusion and promote bone growth. All Camber Spine products are designed and manufactured in the United States, ensuring a high level of quality control and innovation.
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