Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
Health and Human Services Department, Food and Drug Administration | Rule | 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.
Reported by Claire WalshMedical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber.
The item is dated 2026-06-29.
TeamCog is carrying it as a rulemaking report from FederalRegister.gov published documents API.
Health and Human Services Department, Food and Drug Administration | Rule | 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.
The handoff preserves the official source citation and source-completeness evidence supplied by discovery.
Official Source
FederalRegister.gov published documents API. Accessed 2026-06-29T15:00:03.750Z.