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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 NumberS004
Date Received09/25/2023
Decision Date12/21/2023
Product Code PJY 
Advisory Committee Orthopedic
Clinical TrialsNCT01725711
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Your supplement requested approval for material changes from Oilon to PEEK for the bending and torque punch components of Axor II, OPRA Implant System.
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
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