FDA Clears Camber Spine’s SPIRA-A Integrated ALIF

Camber Spine has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its SPIRA-A integrated technology.

SPIRA-A Integrated is now indicated for 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).

The SPIRA-A integrated fixation system is an anterior lumbar interbody fusion (ALIF) device with an open matrix design. This allows packing with autogenous and/or allogeneous graft material to facilitate fusion as well as further fixation options to secure the implant in the disc space.

It has integrated fixation deployed in a traditional ALIF cage and approach. It also has a windswept cage geometry to access L5-S1 with challenging vascular anatomy. Each implant has up to 40 points of endplate contact, according to Camber Spine.

SPIRA-A’s superior and inferior surfaces feature a rough surface to prevent device movement while fusion takes place. Structural arches also help distribute the load across the joint space. Three holes are contained in the device to insert bone screws or anchors, as well as blocking screws to prevent fixation back-out.

The screws and anchors, according to the company, increase fixation in the cortical endplate and offer first-of-their-kind 3D-printed anchors with a SPIRA surface.

“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,” Camber Spine CEO Brooks McAdam told the press. “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.”