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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceREFLECTION CERAMIC ACETABULAR SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116
PMA NumberP030022
Date Received06/11/2003
Decision Date12/17/2004
Withdrawal Date08/31/2022
Product Code MRA 
Docket Number 05M-0027
Notice Date 01/21/2005
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE REFLECTION CERAMIC ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR USE IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, OR TRAUMATIC ARTHRITIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S040 S005 S006 S012 S013 S017 S014 S015 S016 S018 S019 S020 
S021 S030 S031 S033 S032 S034 S035  S022 S023 S024 S025 
S026 S027 S028 S029 S043 S038 S002 S003 S004 S001 S036 S037 
S041 S042 S039 S008 S009 S010 S011 S045 S044 S047 S048 S049 
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