Camber Spine Technologies has launched its Open Matrix ALIF device in the USA following the receipt of 510(k) clearance from the US Food and Drug Administration (FDA).
Spira is an interbody fusion implant consisting of spiral support arches and Surface by Design technology. The 3D-printed device is Camber’s tenth line to be released on the US market.
According to a press release, the device was designed specifically to increase fusion rates and stabilisation. The spiral support arches decrease subsidence by load-sharing over the entire endplate, while also maximising bone graft capacity. The Surface by Design technology is a deliberately-designed roughened surface that should facilitate bone growth through an optimised pore diameter, strut thickness and trabecular pattern.
Spira is indicated for use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1. The device is intended to be used with additional FDA-cleared supplementary fixation systems.
“[Additive] manufacturing technology allows us to create these truly unique patented structures featuring open-arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth,” says Camber Spine chief executive officer, Daniel Pontecorvo. “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.”
