FDA classifies absorbable metal bone-fixation fasteners as Class II (special controls, 2026)

The U.S. Food and Drug Administration (FDA) issued an order classifying absorbable metal bone-fixation fasteners into Class II (special controls), published in the Federal Register.

Bone-fixation fasteners are orthopedic devices (such as screws and pins) used to hold bone fragments in place after fractures or osteotomies. The devices at issue are made of absorbable metal — metal that breaks down and is absorbed in the body over time, potentially avoiding a second surgery for removal.

FDA device classes run by risk: Class I (general controls), Class II (special controls), and Class III (premarket approval). This order places the device type in Class II and identifies the applicable special controls, codifying them in the CFR. Special controls set device-specific requirements (e.g., performance testing and labeling) to provide a reasonable assurance of safety and effectiveness.

[Why it matters] A device's class determines its U.S. regulatory pathway. For developers and regulatory teams working on orthopedic implants — especially absorbable devices — the classification and the applicable special controls are foundational information for product development and market entry.