FDA WARNS NUVASIVE OVER ILIF LABELING (Orthopedics This Week)
The FDA sent NuVasive, Inc. a warning letter on March 12, 2013 related to labeling claims not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s.
The company announced the warning letter on March 18, 2013 and said the regulatory action came from an FDA inspection of the company’s San Diego, California facility last fall. The inspection, according to the company, did not result in any 483 observations nor cite any quality system concerns.
The warning letter only specifies labeling claims related to the company’s ILIF (Interlaminar Lumbar Instrumented Fusion) procedure.
ILIF Procedure
According to the company’s website, NuVasive’s ILIF procedure was developed to overcome the potential shortcomings of standard lumbar spinal stenosis treatments (e.g., decompression alone and decompression with fusion), using a minimally disruptive surgical technique. Minimally disruptive surgical procedures attempt to minimize approach-related muscle pain by avoiding release of the muscle from its bony attachment. The ILIF surgical procedure uses a small incision at the midline of the spine and requires only a sm...
