Metal/polymer hip joints
This article was originally published in The Gray Sheet
Executive Summary
Downclassification of metal/polymer constrained cemented or uncemented hip joint prostheses from Class III to Class II is outlined in a Sept. 5 FDA proposed rule. Copies of a draft special controls guidance document supporting the change, released Sept. 6, can be found at http://www.fda.gov/cdrh/ode/guidance/1328.pdf. FDA's Orthopedic and Rehabilitation Devices Panel unanimously recommended downclassification in November 1999 following a June 1999 petition from the Orthopedic Surgical Manufacturers Association (1"The Gray Sheet" Nov 8, 1999, p. 10). Comments on the draft guidance are due by Dec. 5