FDA classifies medial knee shock absorbers as lower-risk devices

The Food and Drug Administration has officially classified a type of knee implant called the medial knee implanted shock absorber into Class II. This classification means the agency considers these devices safe enough to be sold with specific special controls, rather than requiring the more rigorous premarket approval process reserved for high-risk implants.

Why it matters: This is mostly an administrative update that lowers the regulatory burden for manufacturers of this specific knee implant technology. It does not change how patients receive care today, but it makes it slightly easier for companies to develop and sell similar shock-absorbing knee devices in the future without undergoing the lengthy premarket approval process.

Who it affects

• Medical device manufacturers producing medial knee implanted shock absorbers

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This action was issued by the Food and Drug Administration in the Federal Register; you should check the original document at 21 CFR 888.3610 before relying on it for regulatory compliance.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document