Posterior Cervical Screw System

What Is It?

Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

What Is FDA Product Code NKG?

Posterior Cervical Screw System is FDA product code NKG, Class 2, 21 CFR 888.3075.

What Does It Take to Sell It in the United States?

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 2 clearances under this code; the FDA took a median of 153 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2018. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (3), Process control (2) and Employee error (1).

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