Xenix Wins FDA Nod for Riva Anchor Spinopelvic Fixation System

Xenix Medical has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Riva Anchor spinopelvic fixation system, which was designed to assist sacroiliac (SI) joint fusion at the base of a posterior lumbar or thoracolumbar fusion construct.

The system combines a Riva Anchor SI joint fusion implant with the Riva posterior pedicle fixation system, which earned an FDA nod in June. It features NanoACTIV surface technology and self-harvesting bone apertures designed to support bone growth and fusion. NanoACTIV uses micro- and nanoscale surface textures intended to promote osteogenic differentiation and cellular and biochemical responses.

Key features of the Riva Anchor include self-harvesting bone apertures. A dual-lead, fully threaded implant that accommodates 5.5 mm and 6.0 mm rods, and it can be implanted using navigation, fluoroscopy, or an open approach.

The company is now preparing for commercial launch on a limited basis. Its Lux expandable lumbar interbody fusion system received FDA clearance in June as well.

Comments from Xenix and clinicians

Ryan Phillips, president: “The addition of NanoACTIV surface technology to the rapidly growing spinopelvic market segment cannot be overstated. While competitive technologies attempt fusion or solely rely on stabilization, Riva Anchor is designed to create an environment for true arthrodesis due to NanoACTIV’s osteogenic properties. This is especially important since the SI joint fusion serves as the biomechanical foundation of the entire long fusion construct.”

Todd Abel, MD, neurosurgeon at the University of Tennessee Medical Center Knoxville: “The need to provide stability at the distal end of a long spine fusion construct as well as fuse the SI joints is becoming more and more understood. This is due to the very high biomechanical forces at the end of the construct. The Riva Anchor system is an elegant solution that easily attaches to the base of a unitary posterior rod. I have used several of the existing systems, and there is a recurring issue of inconsistent fusion across the joint, causing haloing or loosening of the screws. What sets the Riva Anchor apart is its NanoACTIV surface—the only spinopelvic system designated by the FDA to have an osteogenic effect.”