Camber Spine gains FDA 510(k) clearance for SPIRA-A AM Integrated Fixation System
July 29, 2024
Camber Spine, King of Prussia, Pennsylvania, USA, has announced that it has received US FDA 510(k) clearance for its SPIRA-A Integrated technology.
The SPIRA-A Integrated Fixation System is an additively manufactured Anterior Lumbar Interbody Fusion (ALIF) 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,” stated 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 is noted to be 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 forty 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 additively manufactured anchors with a SPIRA Surface, designed to increase the potential for osseointegration and resist pull-out.
The inserter attachment, multiple technique possibilities, and a wide variety of screw prep options are designed to facilitate clear visualisation 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).
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