Joint, Knee, External Limb Component

How Is ISY Classified?

Joint, Knee, External Limb Component is FDA product code ISY, Class 1, 21 CFR 890.3420.

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

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 17 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Process control (4), Device Design (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.