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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCERAMIC TRANSCEND ARTICULATION SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantMicroPort Orthopedics Inc.
5677 AIRLINE RD
ARLINGTON, TN 38002-0000
PMA NumberP030027
Supplement NumberS002
Date Received03/08/2006
Decision Date06/23/2006
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
Post-Approval StudyShow Report Schedule and Study Progress
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