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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 NumberS012
Date Received01/16/2026
Decision Date02/12/2026
Product Code PJY 
Advisory Committee Orthopedic
Clinical TrialsNCT01725711
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the replacement of the current laser machine used to create the BioHelix surface with a comparable machine in the manufacturing process.
Post-Approval StudyShow Report Schedule and Study Progress
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