Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

How Is JWH Classified?

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer is FDA product code JWH, Class 2, 21 CFR 888.3560.

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 5 clearances under this code; the FDA took a median of 265 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 984 recalls under this product code since 0013. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Labeling design (149), Nonconforming Material/Component (94) and Process control (81). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.