The US Food and Drug Administration has given 510(k) clearance to Nexxt Spine for its Honour cervical spacer and lumbar spacer implants made of Zeniva polyetheretherketone (PEEK) rods.
Zeniva PEEK (Solvay Specialty Polymers) has a modulus very close to that of bone plus excellent toughness and fatigue resistance. According to Nexxt Spine, the FDA clearance was based in part on Solvay’s well-developed master access file for Zeniva PEEK.
The Honour Spacer system consists of three implants which are offered in various footprints, with indications ranging from the cervical to the lumbar spine. According to the company, the system accommodates unilateral (TLIF and oblique) and bilateral (PLIF) 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. 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,” said Eric Lintula, director of Engineering, Nexxt Spine.
Zeniva PEEK offers numerous advantages over metals such as titanium for these intervertebral implantable devices. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. Based on biocompatibility testing, Zeniva PEEK demonstrates no evidence of cytotoxicity, sensitisation, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures. Nexxt Spine buys Zeniva PEEK rod stock directly from Solvay Specialty Polymers and machines and designs a full range of spacer sizes and configurations.