Posterior Metal/Polymer Spinal System, Fusion

What Is It?

This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

How Is NQP Classified?

Posterior Metal/Polymer Spinal System, Fusion is FDA product code NQP, Class 2, 21 CFR 888.3070.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 50 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Device Design (34), Error in labeling (6) and Equipment maintenance (5).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.