# FTL: Mesh, Surgical, Polymeric

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 337
- 510(k) review time 2021–2025: median 84 days (middle half 29–168)
- Recalls: 46 (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: 6
- 2018: 12
- 2019: 4
- 2020: 5
- 2021: 2
- 2022: 6
- 2023: 4
- 2024: 2
- 2025: 6
- 2026: 2

## Most-cited predicates
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh (2000), cited by 13
- K040998: Modification to Parietex Composite (Pco) Mesh (2004), cited by 13
- K922916: Bard Marlex Mesh Dart (1992), cited by 11
- K810428: Vicryl (1981), cited by 10
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet (2003), cited by 9
- K033337: Ultrapro Mesh (2004), cited by 9
- K992556: Permacol (2000), cited by 8
- K002699: Parietex Composite (Pco) Mesh (2001), cited by 8
- K991400: Parietene Polypropylene Mesh (1999), cited by 8
- K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft (2006), cited by 8

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