The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the medial knee implanted shock absorber. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · June 29, 2026
FDA Classification of Medial Knee Implanted Shock Absorber as Class II Medical Device
Original title: Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
FDA classifies medial knee implanted shock absorber as class II device with special controls to ensure safety and effectiveness.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.