DEPUY ORTHOPAEDICS, INC. RECEIVES FDA PMA SUPPLEMENT APPROVAL FOR CERAMAX® TOTAL HIP SYSTEM WITH BIOLOX® delta CERAMIC-ON-CERAMIC 36MM LARGE FEMORAL HEAD (press release)
DEPUY ORTHOPAEDICS, INC. RECEIVES FDA PMA SUPPLEMENT APPROVAL FOR CERAMAX® TOTAL HIP SYSTEM WITH BIOLOX® delta CERAMIC-ON-CERAMIC 36MM LARGE FEMORAL HEAD
New Ceramic-on-Ceramic Option Provides Additional Choice within PINNACLE® Hip Portfolio in the U.S.
DePuy Orthopaedics, Inc. has received Pre-Market (PMA) Supplement Approval from the U.S. Food and Drug Administration (FDA) for the DePuy CERAMAX® Total Hip System with BIOLOX® delta Ceramic-on-Ceramic 36MM Large Femoral Head. DePuy Synthes Joint Reconstruction is a division of DePuy Orthopaedics, Inc.
This PMA supplement approval for the 36mm size follows the initial PMA approval of the CERAMAX Hip 28mm size in 2010. Upon launch of the CERAMAX System this summer, the company’s PINNACLE® Acetabular Cup System will offer the only FDA approved ceramic-on-ceramic bearing surface with BIOLOX delta Femoral Head, a new, next generation nano composite ceramic material.
The key benefits of BIOLOX delta Ceramic Head are its very high strength and toughness. These properties ...
