FDA panel recommendation cuts Biorthex workload
This article was originally published in Clinica
Executive Summary
The US FDA's orthopaedic panel meeting's recommendation last December that spinal interbody fusion implants should be down-classified from class III to class II devices is welcome news to Biorthex. As a result of the expected risk regrading, the Montreal, Canada-based spinal technology firm no longer needs to carry out the clinical trials required for the premarket approval application of two of its products, but will be able to seek clearance under the less stringent 510(k) procedure.