December 1998 Bulletin

FDA panel recommends approval of Norian system

The FDA Orthopaedics and Rehabilitation Devices Advisory Panel voted 8-1 to recommend approval of Norian's Skeletal Repair System, cancellous bone cement, to be marketed as an adjunct or augmented treatment rather than a primary treatment for unstable radial distal fractures. They recommended labeling conditions that the use of the paste that is injected into a fractured bone could result in radial length loss in the bone and that long-term effects of the device had yet to be determined.

Home Previous Page