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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 NumberS011
Date Received01/15/2026
Decision Date04/15/2026
Product Code PJY 
Advisory Committee Orthopedic
Clinical TrialsNCT01725711
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the following changes: i) changes to the transport packaging box dimensions and configuration, ii) minor changes to the package design of the fixture components; and iii) removal of the repacking step after sterilization
Post-Approval StudyShow Report Schedule and Study Progress
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