FDA Grants 510(k) Clearance for Riva Anchor Spinopelvic Fixation System
1 report, 1 independent
Updated Sep 22
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What happened
Xenix Medical announced the FDA 510(k) clearance for its Riva Anchor Spinopelvic Fixation System on September 22, 2026. The device is designed to facilitate the fusion of the sacroiliac (SI) joint at the base of a posterior lumbar or thoracolumbar fusion construct. The system incorporates NanoACTIV surface technology and self-harvesting bone apertures to support postoperative bone growth and fusion.
From orthospinenews.com
Why it matters
The clearance allows the device to be used in the rapidly growing spinopelvic market segment. The technology is intended to create an environment for true arthrodesis, which is the biomechanical foundation of long fusion constructs.
From orthospinenews.com
Who's involved
- FDAThe U.S. Food and Drug Administration (FDA) is the regulatory body that reviewed and cleared the device.