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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameCERAMIC TRANSCEND ARTICULATION SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantWRIGHT MEDICAL TECHNOLOGY, INC.
PMA NumberP030027
Supplement NumberS002
Date Received03/08/2006
Decision Date06/23/2006
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an intermediate ceramic liner size (36/48g); three replacement 36mm od ceramic heads with consistent offset (-3. 5 mm, 0 mm, and +3. 5 mm); and femoral stems and acetabular shells as specified in submissions received march 8, 2006 and june 21, 2006 which have been round substantially equivalent via the 510(k) process. The device, as modified, will be marketed under the trade name ceramic lineage/ transcend articulation system and is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
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