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

1FDA places absorbable metal bone fixation fasteners in Class II

The U.S. Food and Drug Administration (FDA) issued an order, published in the Federal Register, classifying absorbable metal bone fixation fasteners into Class II (special controls). These are the screws and pins that hold bone fragments after a fracture or osteotomy, made of a metal that breaks down and is absorbed in the body over time.

The special controls for the device type are codified in the Code of Federal Regulations, which settles the regulatory path for bringing similar absorbable implants to the U.S. market. The sections below take the device first, then what its class means.

2What absorbable bone fixation fasteners are

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.

3How FDA device classes work

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.

4Removed, or left in place

What separates a resorbable bone fixation fastener from a conventional one is whether it stays in the body.

Bone fixation fasteners are orthopaedic devices — screws, pins — used to hold bone fragments in fracture or osteotomy. This order places the device type in Class II, with the applicable special controls identified and codified. Special controls set device-specific requirements such as performance testing and labelling.