FDA to require premarket approval for metal-on-metal hips

Editor's Note

The Food and Drug Administration (FDA) on February 18 issued a final order to require the filing of a premarket approval (PMA) application for two types of metal-on-metal total hip replacement devices:

• hip joint metal/metal semi-constrained, with a cemented acetabular component
• hip joint metal/metal semi-constrained, with an uncemented acetabular component.

The FDA has determined that these devices should remain Class III (higher risk), and PMA applications must be filed by May 18, 2016, if a manufacturer wants to continue marketing these devices and/or market new metal-on-metal hip replacement devices.

On February 18, 2016, the FDA issued a final order requiring manufacturers to submit a premarket approval (PMA) application for two types of MoM total hip replacement devices: the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component.