Camber Spine has received US Food and Drug Administration (FDA) 510(k) clearance for both its SPIRA-P posterior lumbar spacer technology and SPIRA-T oblique posterior lumbar spacer technology.
Part of the SPIRA product platform, the SPIRA-P posterior lumbar spacer can be used to accommodate posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) procedures.
The device also features a patented open architecture design for endplate load distribution. Additionally, its surface allows for cell adhesion and bone cell proliferation while its interconnected porosity design mimics bone, says Camber Spine.
The SPIRA-T oblique posterior lumbar spacer features the same qualities, but is designed specifically to accommodate traditional or ‘insert and rotate’ TLIF procedures. Its shape is angled for a 25° oblique insertion technique in order to optimise lordosis.
The FDA’s action means that both of these lumbar interbody fusion devices are now indicated for use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1.
Daniel Pontecorvo, Camber co-founder and CEO, said: “The FDA’s approval of SPIRA-P and SPIRA-T not only marks a major step in our company’s development, it also helps bring more innovation-based solutions and options to the surgical community.
“SPIRA technology provides structural stability following discectomy. SPIRA posterior lumbar spacers have different shapes and designs to accommodate a broader array of posterior and transforaminal approaches and techniques.
“These new products are also significant in that they are our first SPIRA implants available for the TLIF market—the number one interbody market in the US today. To further expand upon this, we look forward to launching an articulating, arched TLIF SPIRA cage product in early 2022.”