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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.
 
DeviceR3 Delta Ceramic Hip System
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Rd.
Memphis, TN 38116
PMA NumberP150030
Supplement NumberS045
Date Received09/03/2024
Decision Date02/28/2025
Withdrawal Date08/11/2025
Product Code MRA 
Advisory Committee Orthopedic
Clinical TrialsNCT03056534
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revisions to device labeling that was updated to include information on the Post-Approval Study (PAS), Short to Mid-term f/u of New US patients PAS, for the R3 Delta Ceramic Hip System.
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