FDA approved prosthetic implant for above-the-knee amputations

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On Dec. 18, 2020, the FDA 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�or above-the-knee�amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.

The OPRA Implant System has been on the market under a humanitarian device exemption since 2015. The OPRA Implant System is manufactured by Integrum AB in M�lndal, Sweden.

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Source: U.S. Food and Drug Administration
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