Nexxt Spine Gains Clearance for Spine Spacers

Fishers, Ind.-based Nexxt Spine LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Honour cervical spacer and lumbar spacer implants made of Zeniva polyetheretherketone (PEEK) rods. The rods are from Solvay Specialty Polymers USA LLC, and are part of Solvay’s line of Solviva Biomaterials. FDA clearance was granted partly based on Solvay’s master access file (MAF) for Zeniva PEEK.

An MAF is part of a premarket approval (PMA) application or an investigational device exemption (IDE) application to the FDA. If a device uses a component or material made by a third party, MAFs on that component or material can be useful and/or necessary for approval or clearance. They contain trade secrets and other confidential material the third party company may not want the PMA/IDE applicant to see, but are willing to provide to the FDA.

Nexxt Spine’s Honour Spacer System consists of three implants, offered in various footprints, with indications ranging from the cervical to the lumbar spine. The system is versatile enough to accommodate unilateral (transforaminal lumbar interbody fusion and oblique) and bilateral (posterior lumbar interbody fusion) approaches in the lumbar spine with the option to insert directly or initially on its side to prevent over-distraction of the ligamentous and nerve structure, according to the company. The spacer systems, made from various sizes of Zeniva PEEK rods, are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae.

“We chose Zeniva PEEK for its similarity to the modulus of elasticity of bone, radiographic properties, and the widespread commercial and regulatory acceptance of the material,” explained Eric Lintula, director of engineering for Nexxt Spine. “Since the core function of the spacer is to restore the original disc height and maintain this height under physiological loads until arthrodesis occurs, having repeatable compressive strength gives our surgeons confidence they will have consistent clinical results.”

Zeniva PEEK is biocompatible and chemically inert. The rods, claims Solvay, also are resilient and resistant to fatigue. Based on biocompatibility testing, Zeniva PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. Its radiolucent properties permit X-ray procedures.

Nexxt Spine buys Zeniva PEEK rod stock directly from Solvay Specialty Polymers. It machines and designs a full range of spacer sizes and configurations.

“We’re excited about the commercial success of Zeniva PEEK in the spinal fusion market,” said Shawn Shorrock, global healthcare market manager for Solvay Specialty Polymers. “The ongoing acceptance of Zeniva PEEK has validated our approach to the spinal market and we’re encouraged by the momentum we’ve generated.”

Located in the Indianapolis, Ind., region, Nexxt Spine LLC manufactures spinal implants and instrumentation.

Headquartered in Alpharetta, Ga., Solvay Specialty Polymers provides high-performance thermoplastics for implantable and non-implantable medical devices.

Photo of Honour cervical spacers made from Zeniva PEEK rods courtesy of Nexxt Spine LLC.