PMA Approved for Above Knee Amputee Implant

FDA has approved an Integrum PMA for Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, intended for adults who have transfemoral (above-the-knee) amputations and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The device is surgically anchored and integrated into a patient’s remaining thigh bone to allow connection to an external prosthetic limb. It has been on the market under a humanitarian device exemption since 2015.

The implant is installed through two surgical procedures. “In the first procedure, a cylinder-shaped fixture is implanted into the central canal of the remaining thigh bone,” FDA says.  “Approximately six months later, after tissue has grown to anchor the fixture and the skin tissue has healed, a second surgery is performed to attach additional device components of the OPRA Implant System to the fixture from the previous surgery.”