MCRA worked with Spinal Kinetics and Orthofix to achieve FDA premarket approval for the Orthofix M6-C artificial disc.
Three things to know:
1. The FDA granted PMA for the M6-C used during procedures to correct single-level cervical disc degeneration. The next-generation artificial disc is designed to mimic the anatomic disc structure.
2. Originally developed by Spinal Kinetics, Orthofix acquired the technology in 2018. MCRA assisted in the clinical trial process and supported the team through PMA submission.
3. Orthofix received approval for the disc in February, 15 months after the initial submission. Prior to this approval, the FDA hadn't granted an original PMA approval for a spine device since 2015.