Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu and Shanghai: 4 hold an FDA registration. 1 is a contract manufacturer.
- Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
- Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
- Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
- Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai
What Is This Device?
This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
What Is FDA Product Code NJL?
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing is FDA product code NJL, Class 3.
What Does It Take to Sell It in the United States?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Has Gone Wrong With It?
The FDA has recorded 269 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Packaging process control (49), Packaging (8) and Software Design Change (7).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.