# LBN: Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene

- Device class: 2; regulation: 21 CFR 874.3495; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1982: 1

## Most-cited predicates

Source page: https://510kreport.com/product-code/LBN
Data by year (CSV): https://510kreport.com/product-code/LBN.csv