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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOPRA Implant System
Generic Nameosseoanchored prostheses for the rehabilitation of transfemoral amputees
Applicant
Integrum AB
krokslatts fabriker 50
molndal Se-43-431
PMA NumberP190009
Date Received04/05/2019
Decision Date12/18/2020
Product Code PJY 
Docket Number 20M-2324
Notice Date 01/28/2021
Advisory Committee Orthopedic
Clinical Trials NCT01725711
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the OPRA Implant System. The device is indicated for patients who have transfemoral amputation due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA Implant System is intended for skeletally mature patients.The patient failed to receive benefit from socket prostheses or is expected to not tolerate socket use due to problems such as:1) Recurrent skin infections and ulcerations in the socket contact area;2) Pain;3) A short stump preventing the use of socket prosthesis;4) Volume fluctuation in the stump;5) Soft tissue scarring;6) Extensive area of skin grafting;7) Socket retention problems due to excessive perspiration; and8) Restricted mobility.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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