Omnia Medical gains FDA clearance for PEEK cervical vertebral body replacement device

Written by Alan Condon | October 01, 2019 | Print  |

The FDA recently provided 510(k) clearance for Omnia Medical's Boxcar.

Four insights:

1. Boxcar is a cervical vertebral body replacement device, designed with Invibio Biomaterial Solutions' PEEK-Optima hyaluronic acid polymer.

2. Hydroxyapatite is incorporated into the PEEK-Optima structure of the implant, which aims to improve patient outcomes.

3. The single-use device allows for adjustments of height and lordosis using spacers and endplates.

4. Boxcar has a hollow center and holes to accommodate autograft or allograft, while promoting bone formation.

More articles on devices:
Dr. Raymond Gardocki: Endoscopic spine surgery in the US — will it catch up to other countries?  
Clarifying patient, provider goals before surgery and robotics in spine: Q&A with Dr. Kris Radcliff
Dr. Isaac Karikari: Changing attitudes toward opioids and how physicians can drive change



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