SpineNet LLC, a US-based manufacturer of spinal fusion implants, has received 510(k) clearance from the Food & Drug Administration (FDA) for its new SpineNet ACC anterior cervical cage made of Zeniva polyetheretherketone (PEEK) rods from Solvay Specialty Polymers USA, LLC.
The new SpineNet ACC cervical cage from SpineNet is designed to reproduce a tri-cortical iliac crest bone, providing structural support as an interbody spacer for anterior cervical fusions. The superior and inferior surfaces allow for intimate contact with the endplate surfaces for optimum stability and to resist subsidence.
The FDA-approved ACC cervical cages are offered in 10x12mm and 12x14mm footprints (5-10 mm height) with multiple sizing options. The ACC implants, made from various sizes of Zeniva PEEK rods, have windows which allow bone to grow through the device, fusing the adjacent bony surfaces of the vertebrae. Radiopaque tantalum rod markers allow for improved positioning. “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 Rick Kitain, Vice President of SpineNet. He added that the company plans to use Zeniva PEEK in future designs of lumbar interbody devices.
Zeniva PEEK offers numerous advantages over metals such as titanium for these intervertebral implantable devices, according to Solvay, 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, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures.
SpineNet buys Zeniva PEEK rod stock directly from Solvay and machines and designs a full range of cervical cage sizes and configurations.