Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance
Omnia Medical (Morgantown, WV) has been granted the first FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (Thornton Cleveleys, UK). The so-called Boxcar system is designed for use in cervical-corpectomy procedures, the replacement of a collapsed, damaged or unstable vertebral body located in the cervical spine.
Robert Gewirtz, a neurosurgeon based in Columbus, OH, collaborated on the development of the Boxcar VBR product. âI see many patients that require a cervical corpectomy, and it's exciting to have such an innovative option for these patients,â he said. âBoxcar is very easy to use and provides intra-operative flexibility, allowing me to dial in a VBR construct to match my patientâs anatomy. Hydroxyapatite is incorporated into the PEEK-Optima structure of the implant, which delivers potentially improved outcomes for my patients,â added Gewirtz.
The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis (the inward curvature of the spine) using spacers and end plates. It features a hollow center and holes to accommodate autograft or allograft, while encouraging the formation of new bone, and includes anti-migration features, noted Invibio.
"There are a limited number of 510(k) FDA cleared cervical VBR products on the market...
Source: MDDI - Category: Medical Devices Tags: Plastics Today Source Type: news
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