|Trade Name||CORMET HIP RESURFACING SYSTEM|
|Classification Name||prosthesis, hip, semi-constrained, metal/metal, resurfacing|
|Generic Name||metal-on-metal hip resurfacing system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new head finishing reamer, the addition of a straight handled mechanical cup introducer and a revised cormet operative technique. The device is indicated for hybrid fixation: cemented femoral head and cementless acetabular component. The cormet hip resurfacing system is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; and 2) inflammatory arthritis such as rheumatoid arthritis. The cormet hip resurfacing system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.