Mass Device , a publication covering the medical device industry, is reporting that Wright Medical Group Inc., an Arlington, Tennessee-based maker of orthopedic medical devices, filed a citizen’s petition with the U.S. Food and Drug Administration to stop rival Smith & Nephew’s Birmingham metal-on-metal hip implant from getting into the U.S. marketplace.
Smith & Nephew, a London-based global medical device maker, has facilities in Memphis.
According to the report, as the FDA in 2006 was reviewing Smith & Nephew’s pre-market approval application for the device — the first metal-on-metal hip implant — Wright filed a citizen’s petition alleging that the study behind the application was not adequate enough to prove the product’s safety and effectiveness. Wright argued that the clinical data behind the pre-market approval application was flawed because it covered the cases of only a single surgeon — Dr. Derek McMinn, inventor of the metal-on-metal hip implant.
The FDA granted two pre-market approvals to Smith & Nephew for the device. The first was in May 2006 and the second came in October of that year for additional sizes.
Wright Medical, meanwhile, has submitted at least two entries in the metal-on-metal class: the company’s Conserve and Lineage implants.
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