Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber

The Food and Drug Administration has classified the medial knee implanted shock absorber into Class II—a regulatory category that speeds patient access while maintaining safety oversight. According to the Federal Register, the agency determined that special controls on this device will provide reasonable assurance of safety and effectiveness without the delays of higher regulatory tiers. It's the FDA cutting through red tape to get an orthopedic innovation to patients faster.

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