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Home » Active Implants back to the drawing board after FDA hearing for Nusurface
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Active Implants back to the drawing board after FDA hearing for Nusurface

May 9, 2023
By Mark McCarty
The regulatory record for successful replacements of the human meniscus is thin, but the latest attempt came up short as a U.S. FDA advisory committee voted 6-2 that the benefits of the Nusurface device by Active Implants LLC did not present an acceptable benefit-risk ratio. The device is commercially available in both the European Union and in Israel, however, suggesting that Memphis, Tenn.-based Active will not give up on the massive U.S. market, which offers a patient population that will undergo a tsunami of total knee replacements in the decades ahead unless a solution for the epidemic of cartilage degeneration can be found.
BioWorld MedTech Regulatory U.S.

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