Identity
- Trade Name
- OPRA Implant System FDA PMA
- Generic Name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees FDA PMA
Identifiers
- PMA Number
- P190009 FDA PMA
- FDA Product Code
- PJY FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The OPRA System is an osseoanchored prosthesis indicated for the rehabilitation of transfemoral amputees. It is intended for skeletally mature 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 device is supplied as part of the OPRA Implant System and is indicated for patients experiencing issues such as recurrent skin infections, pain, short stump, volume fluctuation, soft tissue scarring, extensive skin grafting, socket retention problems due to perspiration, or restricted mobility. It received FDA PMA approval (P190009) and is manufactured by Integrum AB in Mölndal, Sweden.
Frequently asked questions
What is the OPRA System indicated for?
The OPRA System is indicated for skeletally mature 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.
What patient conditions support the use of the OPRA System?
The OPRA System is intended for patients who failed to benefit from socket prostheses or are expected not to tolerate socket use due to recurrent skin infections and ulcerations, pain, short stump, volume fluctuation, soft tissue scarring, extensive skin grafting, socket retention problems from perspiration, or restricted mobility.
Who manufactures the OPRA System and where is it located?
The OPRA System is manufactured by Integrum AB, located at Krokslatts Fabriker 50, Mölndal, SE-431 37, Sweden.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190009 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integrum AB
Sources (1)
- FDA PMA P190009 24 fields · synced Sep 18, 2026