New spinal implant with PEEK receives FDA clearance

US designer and manufacturer of spinal implants, Maxim Surgical, has received 510(k) clearance from the US Food & Drug Administration (FDA) for its new MaxFuse-C cervical interbody fusion system made from Solvay Specialty Polymers’s Zeniva polyetheretherketone (PEEK) rods.

Zeniva PEEK is part of Solvay’s line of Solviva Biomaterials that has a modulus very close to that of bone plus excellent toughness and fatigue resistance. The FDA clearance was based in part on Solvay’s well-developed master access file for Zeniva PEEK.

The cervical interbody fusion system made from Zeniva PEEK rod is hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae. The cervical spacer for the spinal fusion market is Maxim’s first orthopedic implant.

Compared to metals such as titanium for spinal implants, Zeniva PEEK renders more advantages 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, and meets the ASTM F2026 standard. It also boasts high strength and stiffness and has radiolucent properties, which enable x-ray procedures without interference.

The MaxFuse-C cervical interbody fusion system is machined from 16-mm and 20-mm diameter Zeniva PEEK rods. It is available in two footprints – 15-mm x 13-mm and 17-mm x 14-mm in both neutral and six-degree lordotic options – offering surgeons flexibility in meeting different patient anatomies.

The system also provides a large graft window, which facilitates a bigger graft volume for fusion.

The Texas-based implants maker offers an easy-to-use single tray system, which includes simplified instrumentation for all of their available implant options.

Meanwhile, Maxim plans to explore the future use of Zeniva PEEK in a range of other spinal fusion products.


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