OPRA Implant System

FDA Premarket Approval P190009

Pre-market Approval Supplement Details

The opra implant system 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:• recurrent skin infections and ulcerations in the socket contact area• pain• a short stump preventing the use of socket prosthesis• volume fluctuation in the stump• soft tissue scarring• extensive area of skin grafting• socket retention problems due to excessive perspiration• restricted mobility

• Device: OPRA Implant System
• Generic Name: Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
• Applicant: Integrum AB
• Date Received: 2019-04-05
• Decision Date: 2020-12-18
• PMA: P190009
• Supplement: S
• Product Code: PJY
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: Integrum AB krokslatts Fabriker 50 molndal Se-43-431

Supplemental Filings

Supplement Number	Date	Supplement Type
P190009		Original Filing
S002	2021-01-15	Normal 180 Day Track No User Fee
S001	2021-01-15	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
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