Xenix Medical has secured FDA 510(k) clearance for its Riva Anchor Spinopelvic Fixation System, a device designed to support sacroiliac (SI) joint fusion at the base of posterior lumbar and thoracolumbar spinal fusion constructs.

 

The medical device company says the Riva Anchor is the first spinopelvic fixation system to receive an FDA nanotechnology designation tied to an osteogenic effect.

 

The system combines a Riva Anchor SI joint fusion implant with the company’s Riva Posterior Pedicle Fixation System. It features Xenix’s proprietary NanoACTIV surface technology and self-harvesting bone apertures, which are designed to support bone growth and fusion following surgery.

 

NanoACTIV uses micro- and nano-scaled surface textures that the company says have demonstrated specific osteogenic differentiation and an endogenous cellular and biochemical response.

 

Ryan Phillips, President of Xenix Medical, said the technology could address a key challenge in long spinal fusion constructs: achieving both stability and fusion at the SI joints.

 

“The addition of NanoACTIV surface technology to the rapidly-growing spinopelvic market segment cannot be overstated,” commented Ryan Phillips, President of Xenix Medical. 

 

“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.”

 

The Riva Anchor is designed to accept 5.5mm and 6.0mm rods and features a dual-lead, fully threaded implant. The system can be implanted using navigation, fluoroscopy or an open surgical approach and is intended for use with Xenix’s Riva Posterior Fixation System.

 

The company is preparing for a limited commercial launch.

 

"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,” commented Todd Abel, Neurosurgeon at the University of Tennessee Medical Center.

 

"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."