|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|
|Classification Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of summit porocoat stems as a compatible component to the existing 28mm ceramic head.