Xenix Medical Receives FDA Clearance for Riva Anchor Spinopelvic Fixation System
Xenix Medical has announced FDA 510(k) clearance for its Riva Anchor Spinopelvic Fixation System, designed to facilitate fusion of the sacroiliac joint at the base of a posterior lumbar or thoracolumbar fusion construct. The system comprises a Riva Anchor SI joint fusion implant that attaches to the Riva Posterior Pedicle Fixation System, incorporating the company’s signature NanoACTIV surface technology and self-harvesting bone apertures to support postoperative bone growth and fusion.
NanoACTIV is a proprietary combination of micro- and nano-scaled surface textures shown to exhibit specific osteogenic differentiation and an endogenous cellular and biochemical response, earning it an FDA nanotechnology designation. The system accepts 5.5mm and 6.0mm rods, features a dual-lead fully threaded implant, and is designed to be implanted using navigation, fluoroscopy, or an open approach.
Ryan Phillips, President of Xenix Medical, stated that the addition of NanoACTIV surface technology to the rapidly growing spinopelvic market segment cannot be overstated. Phillips noted that 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, which 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, said the need to provide stability at the distal end of a long spine fusion construct as well as fuse the SI joints is becoming increasingly understood due to the very high biomechanical forces at the end of the construct. Abel noted that the Riva Anchor system is an elegant solution that easily attaches to the base of a unitary posterior rod, and that while existing systems have a recurring issue of inconsistent fusion across the joint causing haloing or loosening of screws, what sets Riva Anchor apart is its NanoACTIV surface, the only spinopelvic system designated by the FDA to have an osteogenic effect.
