DePuy wins FDA supplemental approval for ceramic hip implant

April 26, 2013 by Arezu Sarvestani

Johnson & Johnson subsidiary DePuy Orthopaedics won supplemental FDA approval for a new size of its Ceramax ceramic-on-ceramic artificial hip replacement system.

DePuy's Ceramax hip implant

The FDA this month granted supplemental approval to Johnson & Johnson (NYSE:JNJ) and its DePuy Orthopaedics subsidiary for a new size of the Ceramax ceramic-on-ceramic hip implant.

Originally approved in December 2010, Ceramax is indicated for non-cemented use in adult patients undergoing total hip replacement. The implant contains some metal components, but is a break from the metal-on-metal hip implants that have mired the company in lawsuits and headlines since a recall in 2010.

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The Ceramax implant features a metal hip stem, a ceramic femoral head, a metal acetabular shell and a ceramic insert that fits into the acetabular shell, according to the FDA approval notice. "The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move," the notice reads.

The latest supplemental PMA was submitted to include a new 36 mm ceramic femoral head and related components, according to the FDA safety & effectiveness summary.