Surface technology company Orthobond has received FDA de novo clearance for its mariner pedicle screw system with Ostaguard coating.
The clearance marks the first spine device treated with a coating that can reduce bacterial contamination in the operating room, according to a May 7 press release.
Orthobond was backed by healthcare advisory firm MCRA, which helped the company with its "pre-submission efforts in gaining FDA feedback to their proposed performance testing suite for their Ostaguard antibacterial technology," according to the release.
MCRA's spine team developed the regulatory strategy and supported Orthobond through the entirety of the FDA process and submitted the de novo on Orthobond's behalf.
The FDA granted clearance to the Ostaguard antibacterial coating April 5.