FDA clears 1st spinopelvic fixation system with nanotechnology designation

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Xenix Medical received FDA 510(k) clearance for its Riva Anchor spinopelvic fixation system.

The system is designed to facilitate fusion of the sacroiliac joint at the base of a posterior lumbar or thoracolumbar fusion construct, according to a Sept. 22 news release.

The Riva Anchor system incorporates Xenix Medical’s NanoACTIV surface technology and self-harvesting bone apertures. It is intended for use with the company’s Riva posterior fixation system and accepts 5.5- and 6.0-millimeter rods.

Xenix Medical is preparing for a limited commercial launch.

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