Thermoplastic Biomaterial Brings High Performance to New Spinal Spacer System Devices

Septemebr 24 2012

Nexxt Spine LLC, a Fishers, Ind.-based manufacturer of spinal implants and instrumentation, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Honour cervical spacer and lumbar spacer implants made of Zeniva polyetheretherketone (PEEK) rods from Solvay Specialty Polymers USA, LLC. Zeniva PEEK – part of Solvay’s line of Solviva Biomaterials – 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.

Nexxt Spine’s new Honour Spacer System consists of three unique implants which are offered in various footprints, with indications ranging from the cervical to the lumbar spine. The system is versatile enough to accommodate 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, 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,” said Eric Lintula, Director of Engineering for Nexxt Spine.

Lintula added that the use of Zeniva PEEK in the structural portion of the spacer resulted in extraordinary repeatability. “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,” explained Lintula.

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, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures.

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