FDA approves Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device- Integrum AB

The FDA has authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device from Integrum AB, instead uses fixtures and screws implanted into the patient’s remaining thigh bone to connect an external prosthetic limb.

The OPRA device received a Humanitarian Use Device (HUD) designation and was reviewed through the Humanitarian Device Exemption (HDE) pathway. An HDE is an application that is similar to a premarket approval application (PMA) but it is exempt from the effectiveness requirements that apply to PMAs. Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the U.S. per year. In order to receive HDE approval for a HUD, a company must demonstrate safety and probable benefit of the device (i.e. that the device will not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit of the device outweighs the risk of injury or illness from its use), and that there are no legally marketed comparable devices, other than a device approved under the HDE or investigational device exemption (IDE) available to treat or diagnose the disease or condition.

Comment: A conventional leg prosthesis uses a specially-fitted cup-like shell called a socket that fits over the remaining portion of the patient’s leg (the residual limb) to secure the device to the leg. Some patients may not have a long enough residual limb to properly fit a socket prosthesis or may have other conditions, such as scarring, pain, recurrent skin infections, or fluctuations in the shape of the residual limb that prevent them from being able to use a prosthesis with a socket.