Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

How Is KWA Classified?

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) is FDA product code KWA, Class 3, 21 CFR 888.3330.

How Does It Reach the US Market?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.

What Has Gone Wrong With It?

The FDA has recorded 203 recalls under this product code since 2008. 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 (83), Employee error (27) and Process control (20). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.