FDA classifies bone void filler with antibiotic as Class II device

The Food and Drug Administration has officially classified a specific medical product called CERAMENT G into Class II. This product is a resorbable calcium salt bone void filler that contains an approved aminoglycoside antibacterial. It is designed to fill gaps in bones, particularly in the extremities where there is a higher risk of infection.

Why it matters: This classification reduces the regulatory hurdles for manufacturers of this specific type of bone filler. By placing it in Class II, the FDA creates a precedent that other similar devices can follow using a less burdensome approval path called 510(k). This is intended to speed up access to beneficial innovations for patients without compromising safety.

Who it affects

• Medical device manufacturers producing resorbable calcium salt bone void fillers with antibiotics

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This final order was issued by the Food and Drug Administration within the Department of Health and Human Services; readers should consult the full Federal Register document for complete technical specifications and compliance requirements.

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