Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

What Is This Device?

Replacement of the humeral head for total anatomic shoulder arthroplasty

How Is PKC Classified?

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained is FDA product code PKC, Class 2, 21 CFR 888.3660.

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. 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 Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Packaging change control (1) and Labeling mix-ups (1).

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