Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

What Is It?

Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.

How Is PAO Classified?

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented is FDA product code PAO, Class 2, 21 CFR 888.3660.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2013. None was by a company in China. 1 is Class I, the most serious grade.

The root cause the FDA records most often is Device Design (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.