# MNU: Staple, Absorbable

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 58 days (middle half 53–108)
- 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)
- 2001: 1
- 2022: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K011172: Arthrex Bio-Transfix (2001), cited by 4
- K212594: OSSIOfiber® Staple (2022), cited by 2
- K233302: OSSIOfiber® Compression Staple (2023), cited by 1

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