FDA Approves Update of Mobi-C Cervical Disc Labeling to Include 7-Year Clinical Results

By Julie A. Vetalice

FDA approved an update to the labeling for Zimmer Biomet’s Mobi-C® Cervical Disc to include 7-year clinical results. The updated data is consistent with previous findings at 60 months, that at 84 months of follow-up, Mobi-C is statistically non-inferior in overall study success for 1-level use and statistically superior in terms of overall study success for 2-level use.

Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis designed as a bone-sparing, cervical intervertebral disc replacement, and is the only FDA-approved disc for 1- and 2-level use.

The seven-year, prospective, randomized clinical trial compared cTDR with Mobi-C to ACDF and followed ~600 patients. The study showed that cTDR with Mobi-C was associated with nominally lower pain scores, maintained range of motion and resulted in less adjacent level degeneration and adjacent level subsequent surgery, as well as a lower rate of secondary surgery compared to ACDF.

The study was published in the International Journal of Spine Surgery in March.

Source: Zimmer Biomet; ORTHOWORLD, Inc.

Product Labels: Spine Artificial Disc

Tags: 510(k) Clearance, Regulatory