Orthofix earns FDA premarket approval for M6-C artificial disc: 3 details

Written by Laura Dyrda | March 07, 2019 | Print  |

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.

More articles on orthopedic devices:
38 orthopedic devices receive FDA 510(k) clearance in February
The spine surgery devices, techniques that won't stand the test of time
Vertos Medical's minimally invasive lumbar stenosis treatment receives international approval: 3 notes

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