Maxim Surgical, based in Richardson, TX, USA is a new entrant in the orthopaedic and spinal fusion market. A medical device distributor for more than tenyears, the company recently expanded into manufacturing and launched its first orthopaedic implant, a cervical spacer for the spinal fusion market. Maxim Surgical received 510(k) clearance from the US Food & Drug Administration (FDA) for its new MaxFuse-C cervical interbody fusion system made of Zeniva polyetheretherketone (PEEK) rod from Solvay Specialty Polymers, Alpharetta, GA, USA, a leadingglobal supplier of high-performance thermoplastics for implantable and non-implantable medical devices.
MaxFuse-C cervical interbody fusion system made of Zeniva polyetheretherketone (PEEK) rod (photos: Solvay)
“Zeniva PEEK is the ‘go-to material’ for interbody spacers due to its high-performance capabilities for spinal fusion surgery,” said Chris Reeg, President of Maxim Surgical. “We have a high level of confidence in this polymer because of its outstanding track record in terms of strength and biocompatibility; it has become an industry standard for implantable medical devices.” Maxim Surgical was exclusively a distributor of spinal and orthopaedic implants for more than decade until it decided to make a foray into manufacturing in order to reduce the cost of goods, bolster its competitiveness and expand market reach.
Reeg selected Solvay as material supplier because Zeniva PEEK had already been qualified by the FDA for many predicated devices that were developed by leading manufacturers. Solvay offered more competitive pricing and simpler, less stringent contractual arrangements. The material supplier worked closely with Maxim Surgical throughout the 18-month product development cycle, providing material specifications, compliance certificates, and prompt material shipments during development, testing, and final commercialisation, according to Reeg.
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 orthopaedic implant.
Implant made from Zeniva PEEK rod is hollow so that bone can grow through the device
Zeniva PEEK, part of Solvay’s line of Solviva Biomaterials – offers numerous advantages over metals such as titanium for spinal implants. The material delivers benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone plus excellent toughness and fatigue resistance.
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 16mm and 20mm diameter Zeniva PEEK rods. It is available in two footprints – 15mm x 13mm and 17mm x 14mm in both neutral and 6° 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. Maxim offers an easy-to-use single tray system which includes simplified instrumentation for all of their available implant options.
Tray system including simplified instrumentation for all Maxim implant options
The manufacturing site for Zeniva PEEK and other Solviva Biomaterials in Alpharetta, GA, is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an ISO 17025 accredited lab.
Privately-owned Maxim Surgical, which maintains close working relationships with surgeons and hospitals, expects to utilise Zeniva PEEK in other future implant products including lumbar interbody spacers which are expected to be commercialised next year. Plans also include an expansion of its distribution network and entry into international markets, according to Reeg.
In addition to Zeniva PEEK, Solvay’s Solviva Biomaterials line includes Veriva polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and good biocompatibility; Eviva polysulphone (PSU), which offers practical toughness in a strong, transparent polymer; and Proniva self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastics that offers good biocompatibility and hardness. These sterilisable products are available in injection moulding and extrusion grades as well as rods and plates for machined components.
www.maximsurgical.com
www.solvayspecialtypolymers.com
