# FTR: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

- Device class: 3; regulation: 21 CFR 878.3540; FDA's rule: PMA required
- FDA decisions: 6
- Recalls: 3 (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)
- 2017: 33
- 2018: 11
- 2019: 14
- 2020: 10
- 2021: 21
- 2022: 8
- 2023: 10
- 2024: 20
- 2025: 16
- 2026: 15

## Most-cited predicates

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