Total Shoulder Arthroplasty System
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Shanghai.
- Arthrex (Shanghai) Co., Ltd. Shanghai
What Is It?
To treat pain and lack of function in the shoulder.
What Is FDA Product Code QHQ?
Total Shoulder Arthroplasty System is FDA product code QHQ, 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 Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2025. None was by a company in China. The root cause the FDA records most often is Process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.