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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameOPRA IMPLANT SYSTEM
Classification Nameosseoanchored prostheses for the rehabilitation of transfemoral amputees
Generic Nameosseoanchored prostheses for the rehabilitation of transfemoral amputees
Applicant
INTEGRUM AB
lilla bommen 1
goteborg SE-41-411
HDE NumberH080004
Supplement NumberS001
Date Received11/06/2015
Decision Date01/20/2016
Product Code
PJY[ Registered Establishments with PJY ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the new axor ii component. The device, as modified, will be marketed under the trade name osseoanchored prostheses for the rehabilitation of amputees (opra) device and the opra device is indicated for patients who have transfemoral amputation due to trauma or cancer and who have rehabilitation problems with, or cannot use, conventional socket prosthesis. The opra device is intended for skeletally mature patients. The patient failed to receive benefit from a socket prostheses due to problems such as: recurrent skin infections and ulcerations in the socket contact area1) pain; 2) a short stump preventing the use of socket prosthesis;3) volume fluctuation in the stump; 4) soft tissue scarring; 5) extensive area of skin grafting;6) socket retention problems due to excessive perspiration; and7) restricted mobility.
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