Constrained Hip Prostheses Downclassification Backed For No-Option Cases
This article was originally published in The Gray Sheet
Executive Summary
Labeling for constrained metal/polymer hip joint prostheses should clearly indicate that the devices be used only when "all other options have been exhausted," FDA's Orthopedic and Rehabilitation Devices Panel recommended Nov. 4 as a condition for downclassifying the devices into Class II.
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Metal/polymer hip joints
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 Comments on the draft guidance are due by Dec. 5
Metal/polymer hip joints
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 Comments on the draft guidance are due by Dec. 5
Metal Hip PMAs Low Priority, But Data Lacking for Class II Status, Panel Says
Metal-on-metal hip joint prostheses lack adequate long-term follow-up data to justify downclassification to Class II, FDA's Orthopedic and Rehabilitation Devices Advisory Panel determined at an Aug. 8 meeting in Gaithersburg, Maryland.