Medical devices; reclassification and codification of hip joint metal polymer/metal semi-constrained porous-coated uncemented prosthesis--FDA. Final rule.

The Food and Drug Administration (FDA) is announcing the reclassification and codification of the hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. FDA issued an order in the form of a letter to two manufacturers reclassifying the device from class III into class II. Accordingly, FDA is amending the regulations as set forth below.