Camber Spine Technologies receives FDA 510(k) clearance for interbody fusion implant

Camber Spine Technologies announced it has received FDA 510(k) clearance for the SPIRA open matrix anterior lumbar interbody fusion device.

The implant is indicated for skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1. The implant features spiral support arches and Surface by Design technology.

According to a company press release, the implant was designed to increase fusion rates and stabilization. By load sharing over the entire endplate, the spiral support arches decrease subsidence and maximize bone capacity. The Surface by Design technology is a specifically designed rough surface that promotes bone growth, according to the release.

“Camber Spine is very excited to be launching our first in a series of spinal implants using 3-D printed-additive manufacturing,” Daniel Pontecorvo, chief executive officer of Camber Spine, said in the release. “This specialized manufacturing technology allows us to create these truly unique patented structures featuring open arched matrixes and proprietary surfaces designed to enhance fusion and promote bone growth. In the coming months, we will be launching a series of five SPIRA spinal interbody cages for cervical, lateral and posterior lumber spine. Extremity implants and custom implants for salvage and complex deformity implants are also under development.”

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