DePuy Orthopaedics inched a step closer to Food & Drug Administration approval of its experimental ceramic-on-metal hip replacement implant, after a federal watchdog agency review of the device indicated it’s no better or worse than already-approved implant technologies, according to news reports.
The Warsaw, Ind.-based Johnson & Johnson subsidiary’s “Complete Acetabular Hip System” would be the first ceramic-on-metal implant to be sold in the United States. Although the FDA review found that the device doesn’t substantially reduce the accumulation of metal ions in the body, it issued a generally positive review and will ask an agency panel to recommend whether to approve the implant. The FDA usually follows such panels’ recommendations.
The company hoped that the ceramic-on-metal design would bring an improvement in wear over current metal-on-metal designs. But the review found that “the ceramic- on-metal ion levels were not statistically different than those determined for metal-on-metal bearings,” according to the report. “It would appear from these results that the presumed benefit of the new bearing surface couple … is limited.”