Wright Medical filed a citizen's petition with the FDA to block pre-market approval of rival Smith & Nephew's Birmingham metal-on-metal hip implant.
Wright Medical (NSDQ:WMGI) sought to block rival Smith & Nephew (FTSE:SN, NYSE:SNN) from getting its Birmingham metal-on-metal hip implant into the U.S. marketplace, according to filings with the FDA.
As the federal watchdog agency in 2006 was reviewing Smith & Nephew's pre-market approval application for the device, which was the first metal-on-metal hip implant, Wright filed a citizen's petition alleging that the study behind the PMA application was inadequate to prove safety and effectiveness.
The FDA granted 2 PMA's to Smith & Nephew for the device, first in May 2006 and another in October of that year for additional sizes. Wright Medical itself has at least 2 entries in the metal-on-metal class, its Conserve and Lineage implants.
Wright argued that the clinical data behind the PMA was flawed because it covered only a single surgeon's cases – the inventor of the metal-on-metal hip implant, Dr. Derek McMinn.
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