Camber Spine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its SPIRA-A Integrated Fixation System for anterior lumbar interbody fusion (ALIF) procedures.
The SPIRA-A Integrated, part of the SPIRA product platform, is an anterior lumbar interbody fusion (ALIF) device that features an open matrix design.
This design allows the packing of autogenous and/or allogenous graft material to facilitate fusion.
With the FDA's clearance, the SPIRA-A Integrated is now indicated for use at one or more levels from L1-S1 in skeletally mature patients.
It is suitable for a variety of conditions, including degenerative disc disease (DDD), disc herniation with myelopathy and/or radiculopathy, deformity, spondylolisthesis, spinal stenosis, and for patients with a failed previous fusion (pseudarthrosis).
Designed to provide a comprehensive solution for the ALIF procedure, the device includes integrated fixation within a traditional ALIF cage and approach.
It also includes a windswept cage geometry tailored for accessing the L5-S1 disc space in the presence of challenging vascular anatomy.
The device offers extensive endplate contact, with up to 40 points of interaction.
To enhance stability during the fusion process, the SPIRA-A Integrated device has superior and inferior surfaces with a rough texture.
It also incorporates structural arches to distribute the load across the joint space effectively. The device features three holes for the insertion of bone screws or anchors, which are complemented by blocking screws to stop fixation back out.
The screws and anchors of the SPIRA-A system are specifically designed to augment the performance of the cage and improve fixation in the cortical endplate. They provide 3D-printed anchors with a SPIRA Surface to enhance osseointegration and resist pull-out.
The system's robust inserter attachment and multiple technique possibilities, along with a range of screw prep options, are intended to ensure clear visualisation and easy access to the surgical site.
Camber Spine's SPIRA implants are manufactured using 3D printing technology.
In 2020, Camber Spine launched the SPIRA- C Integrated Interbody System and the FORTICO Anterior Cervical Plating System.
