# FTM: Mesh, Surgical

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 164
- 510(k) review time 2021–2025: median 93 days (middle half 30–187)
- Recalls: 48 (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)
- 2016: 7
- 2017: 9
- 2018: 2
- 2019: 6
- 2020: 4
- 2021: 4
- 2023: 2
- 2024: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K980431: Surgisis (1998), cited by 29
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc (1998), cited by 13
- K034039: Sis Plastic Surgery Matrix (2004), cited by 12
- K070560: LRTM Surgical Mesh (2007), cited by 10
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), cited by 10
- K923657: Supple Peri-Guard (1992), cited by 9
- K013625: Permacol (2002), cited by 9
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), cited by 8
- K050337: Sis Fistula Plug (2005), cited by 8
- K053655: Tendon Wrap Tendon Protector (2006), cited by 7

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