8/29/2017

FDA Clears 3D-Printed Spinal Implant

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Camber Spine Technologies can now market its additively manufactured Spira open-matrix ALIF device.

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Camber Spine Technologies announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its 3D-printed Spira open-matrix ALIF device, an interbody fusion implant with spiral support arches and Surface by Design technology.

Additive manufacturing enables the company to create the implant’s open-arched matrices and surfaces designed to enhance fusion and stabilization, and promote bone growth. The arches are said to decrease subsidence by load sharing over the entire endplate, while maximizing bone graft capacity. The company’s Surface by Design technology results in a roughened surface to facilitate bone growth through optimized pore diameter, strut thickness and a trabecular pattern.

The company will launch a series of five Spira spinal interbody cages for different areas of the spine, as well as extremity and custom implants.

The implant is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1 and is intended to be used with additional FDA-cleared supplementary fixation systems. This is the company’s tenth line of spinal implant systems to be released in the U.S.

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