Following years of development efforts, ULTAMET® Metal-on-Metal Articulation was cleared for sale in the U.S. through the FDA’s 510(k) process in 2000. The 510(k) process is a regulatory pathway established by Congress that has been used for a majority of medical devices on the market.
Outside the U.S., ULTAMET Metal-on-Metal was reviewed starting in 2001 by multiple regulatory authorities around the world and approved for sale in each country where it was reviewed.
At various points in time, DePuy provided risk information and clinical performance data related to the ULTAMET Metal-on-Metal to regulatory bodies, including the FDA. There is also information publicly available through published literature, presentations at industry conferences, and international registries.1
- Annual reports for the National Joint Registry for England and Wales (UK NJR) and for the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) can be found here: UK NJR http://www.njrcentre.org.uk/njrcentre/Reports,PublicationsandMinutes/Ann... ; AOA NJRR http://aoanjrr.dmac.adelaide.edu.au/