The US Food and Drug Administration (FDA) approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, manufactured by Integrum AB in Mölndal, Sweden. It is the first implant system marketed in the United States for adults who have transfemoral amputations.
“Today’s approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses,” said Capt. Raquel Peat, PhD, MP, USPHS, director of the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices.
The OPRA system, which is surgically anchored and integrated into the patient’s residual thigh bone to allow connection to an external prosthetic limb, has been on the market under a humanitarian device exemption since 2015. Humanitarian use devices are intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.
The FDA evaluated the implant’s safety and effectiveness in a clinical study of 65 participants who received the implant. Effectiveness was assessed using the Questionnaire for Persons with a Transfemoral Amputation, a patient-reported outcome measure about frequency of use, mobility, problems with the device, and the patient’s overall health. The average improvement in the prosthetic use score on a 100-point scale, was 35.1 points at two years and 39.6 points at five years compared to their reported scores with a conventional socket prosthesis.
The FDA reviewed the OPRA Implant System under the Premarket Approval (PMA) pathway. PMA is the most stringent type of device marketing application required by the FDA and is based on a the FDA’s determination that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use.