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The 510(k) Ancestry of a Metal-on-Metal Hip Implant

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

Many medical devices that pose great safety risks to Americans, including metal-on-metal hip implants, currently enter the U.S. market through a Food and Drug Administration (FDA) regulatory pathway that is not intended for evaluating safety and effectiveness. This pathway, called the 510(k) process, instead involves evaluation of “substantial equivalence” to previously cleared devices, many of which have never been assessed for safety and effectiveness and some of which are no longer in use because of poor clinical performance.

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