Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener
Key claim: The FDA is classifying the absorbable metallic bone fixation fastener as a Class II medical device subject to special controls, determining this provides reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the absorbable metallic bone fixation fastener 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 absorbable metallic bone fixation fastener. 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.
Why this matters
Class II classification with special controls establishes a defined regulatory pathway for absorbable metallic bone fixation fasteners, letting manufacturers rely on 510(k) clearance rather than premarket approval. For orthopedic patients and surgeons, this can broaden access to bioabsorbable fixation options that dissolve over time and may reduce the need for hardware-removal surgeries.