NuVasive gains FDA 510(k) clearance for porous PEEK implant used in XLIF procedures

The NuVasive Cohere Porous PEEK implant has received FDA 510(k) clearance from the FDA. The implant, which involves proprietary patented PEEK technology and 3-D architecture, is used in extreme lateral interbody fusion or XLIF spine procedures, according to a company press release.

The FDA 510(k) indications for Cohere allow surgeons to use the implant with autograft and/or allograft in skeletally mature patients with thoracolumbar pathologies that include degenerative disc disease, degenerative spondylolisthesis and degenerative scoliosis. The implant material’s porous structure promoted bone on-growth and in-growth in preclinical studies, which is key to facilitating fusion, as noted in the release.

“It’s exciting to extend our patented interbody technology to the company's flagship XLIF procedure, an integral part of our single-position surgery portfolio, as we further our mission to improve patient lives,” Matt Link, president of strategy, technology and corporate development for NuVasive, said in the release. “Cohere XLIF represents the first buildout of a porous PEEK implant by NuVasive, and we look forward to extending this proprietary technology into additional applications across the company's comprehensive procedural solutions.”

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