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Trade Name | OPRA IMPLANT SYSTEM |
Classification Name | osseoanchored prostheses for the rehabilitation of transfemoral amputees |
Generic Name | osseoanchored prostheses for the rehabilitation of transfemoral amputees |
Applicant |
INTEGRUM AB |
lilla bommen 1 |
goteborg SE-41-411 |
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HDE Number | H080004 |
Supplement Number | S001 |
Date Received | 11/06/2015 |
Decision Date | 01/20/2016 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
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. |