PEEK-manufactured cervical 'boxcar' given FDA approval

Omnia Medical’s ‘Boxcar’ has been granted FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions.

The Boxcar system has been designed for use in cervical-corpectomy procedures – that is, the replacement of a collapsed, damaged, or unstable vertebral body located in the cervical spine.

Robert Gewirtz, neurosurgeon, Columbus, Ohio, collaborated on the development of the Boxcar VBR product.

He said: “I see many patients that require a cervical corpectomy, and it's exciting to have such an innovative option for these patients. Boxcar is very easy to use and provides intra-operative flexibility, allowing me to dial in a VBR construct to match my patient’s anatomy. Hydroxyapatite is incorporated into the PEEK-OPTIMA structure of the implant, which delivers potentially improved outcomes for my patients.”

The single-use device is available in two footprints and allows adjustments of height and lordosis using spacers and endplates. It features a hollow centre and holes to accommodate autograft or allograft, while encouraging the formation of new bone, and includes anti-migration features.

Steve Anderson, vice president of marketing at Omnia Medical, said: “There is a limited number of 510(k) FDA cleared cervical VBR products on the market, and for our company to gain the first approval for a PEEK-OPTIMA HA Enhanced cervical corpectomy device is a great achievement. I’m absolutely confident surgeons will see the clinical benefits for them and their patients. Omnia Medical is focused on bringing truly innovative products to market, and Boxcar is the first of many ‘first to market’ products from our company, going forward.”