FDA Approves Screws That Dissolve Inside Your Bones
Published Date: 6/5/2026
Rule
Summary
The FDA is officially classifying absorbable metallic bone fixation fasteners as Class II devices with special safety rules, making them easier to get to patients while keeping them safe and effective. This change helps doctors and patients by reducing red tape and encouraging new, helpful bone-fixing tech. The new rules took effect on June 5, 2026, but have been in place since March 29, 2023, so manufacturers should already be on board.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
New Clinical, Testing, and Labeling Requirements
Manufacturers must meet special controls including clinical data showing full absorption, non-clinical performance testing (complete degradation profile, initial and degrading mechanical performance), biocompatibility, non-pyrogenicity, sterility and shelf-life testing. Labeling must include material composition, absorption byproducts, technical parameters, expiration/shelf life, instructions for revision surgery, time to complete absorption, and a summary of clinical data.
Absorbable Fixators Reclassified to Class II
The FDA has classified absorbable metallic bone fixation fasteners as Class II with special controls. The final order is effective June 5, 2026, and the classification has been applicable since March 29, 2023. FDA says this change reduces regulatory burdens and will enhance patients' access to these devices.
Creates Predicate Pathway for Future Devices
Because FDA used the De Novo process to classify this device, the absorbable metallic bone fixation fastener can serve as a predicate for future similar devices. Other device sponsors can use the less-burdensome 510(k) process instead of submitting a De Novo request or a premarket approval application for substantially equivalent devices.
510(k) Premarket Notification Still Required
FDA states that absorbable metallic bone fixation fasteners are subject to premarket notification under section 510(k). At this time, FDA has not determined that this device type should be exempt under section 510(m), so sponsors must submit a 510(k) before marketing.
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