Intervertebral Fusion Device With Bone Graft, Lumbar

What Is It?

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

How Is MAX Classified?

Intervertebral Fusion Device With Bone Graft, Lumbar is FDA product code MAX, Class 2, 21 CFR 888.3080.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 10 clearances under this code; the FDA took a median of 185 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 115 recalls under this product code since 2005. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Device Design (27), Nonconforming Material/Component (23) and Labeling Change Control (8). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.