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DePuy Receives FDA Supplemental Pre-Market Approval for Hip Devices

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Warsaw, Ind.-based DePuy Orthopaedics received FDA pre-market supplement approval for its CERAMAX total hip system and BIOLOX delta ceramic-on-ceramic 36mm large femoral head.
The CERAMAX received initial PMA approval for the 28mm size in 2010 and now has approval for the additional 8mm. When CERAMAX is launched in the summer, the PINNACLE Acetabular Cup System will be the only ceramic-on-ceramic bearing surface with the BIOLOX delta Femoral Head, according to the release.

The devices expand the company’s PINNACLE Hip Solutions portfolio of instruments, implants, materials and solutions for surgeons and patients.

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