alexa FDA Approves: Rehabilitation Device of Above-the-Knee Amputations

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FDA Approves: Rehabilitation Device of Above-the-Knee Amputations

The U.S. Food and Drug Administration have authorized use of the first prosthesis marketed in the US for adults who have amputations above the knee. The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device instead uses fixtures and screws implanted into the patient's remaining thigh bone to connect an external prosthetic limb. Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities.

The OPRA device received a Humanitarian Use Device (HUD) designation. Data supporting the safety and probable benefit of the OPRA device included mechanical testing of the device's parts when subjected to weight, twisting, bending and simulated repeated use, and a two-year, 51-subject clinical trial. The OPRA device is manufactured by Integrum AB in Molndal, Sweden.

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