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FDA grants clearance for PEEK-Optima HA vertebral body replacement system

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Invibio Biomaterial Solutions announced that the Omnia Medical VBR system became the first product made of polyetheretherketone or PEEK- Optima hydroxyapatite, which is an advanced polymer, to receive FDA 510(k) clearance, according to a press release.

Invibio partnered with Omnia Medical and Jalex Medical on product development.

The Omnia Medical VBR is used to replace a collapsed, damaged or unstable vertebral body in the thoracolumbar spine.

“We are happy to be the first to be granted FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA [hydroxyapatite] HA Enhanced biomaterial,” Steve Anderson, vice president of marketing at Omnia Medical, said in the release. “This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure. Working with Jalex Medical and Invibio Biomaterial Solutions was an excellent experience and will hopefully enable surgeons and patients to benefit from the new solutions.”

Reference:

www.omniamedical.com