The U.S. Food and Drug Administration (FDA) has approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for adults who have transfemoral amputation and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA Implant System is manufactured by Integrum AB in Mölndal, Sweden, which has a U.S. office in San Francisco.
The FDA evaluated the safety and effectiveness in a clinical study of 65 participants who received the OPRA Implant System, which has been on the market under a humanitarian device exemption since 2015. Effectiveness was assessed using the Questionnaire for Persons with a Transfemoral Amputation, a patient reported outcome measure that reflects frequency of use, patient’s mobility, problems with the device, and patient’s overall health. The average improvement in the prosthetic use score on a 100-point scale, was 35.1 points at 2 years and 39.6 points at 5 years as compared to their reported scores with a conventional socket prosthesis.