Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jiangsu and Zhejiang: 3 hold an FDA registration. 3 are contract manufacturers.
- Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
- Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code KRQ?
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer is FDA product code KRQ, Class 2, 21 CFR 888.3550.
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 1 recall under this product code since 2022. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.