Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Zhejiang: 3 hold an FDA registration.
- Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
- Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
- Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
What Is It?
This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
How Is NRA Classified?
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing is FDA product code NRA, Class 3.
How Does It Reach the US Market?
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 Do the Recalls Say?
The FDA has recorded 32 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (17), PMA (13) and Device Design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.