|Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.|
|Trade Name||KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM|
|Classification Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Generic Name||ceramic/ceramic hip|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the product development protocol (pdp) for the keramos ceramic/ceramic total hip system. This device is indicated for usc in patients requiring primary total hip arthroplasty for the treatment of inflammatory tissue disorders and noninflammatory degenerative joint disease, including osteoarthritis, post-traumatic arthritis or secondary arthritis, and avascular necrosis.