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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceOPRA Implant System
Generic NameOsseoanchored prostheses for the rehabilitation of transfemoral amputees
ApplicantIntegrum AB
Krokslatts Fabriker 50
Mölndal SE-431 37
PMA NumberP190009
Supplement NumberS010
Date Received09/26/2025
Decision Date03/12/2026
Product Code PJY 
Advisory Committee Orthopedic
Clinical TrialsNCT01725711
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 the device labeling that was updated to include information on the Post-Approval Study (PAS), TFAOS PAS, for the OPRA Implant System
Post-Approval StudyShow Report Schedule and Study Progress
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