Thoracolumbosacral Pedicle Screw System

What Is This Device?

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

How Is NKB Classified?

Thoracolumbosacral Pedicle Screw System is FDA product code NKB, 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. Chinese applicants hold 15 clearances under this code; the FDA took a median of 134 days from receipt to decision on them. 3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 181 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 (55), Nonconforming Material/Component (34) and Process control (11). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.