# GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

- Device class: 2; regulation: 21 CFR 878.5000; FDA's rule: 510(k) required
- FDA decisions: 176
- 510(k) review time 2021–2025: median 122 days (middle half 75–216)
- Recalls: 6 (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: 6
- 2019: 4
- 2020: 5
- 2021: 4
- 2022: 5
- 2023: 8
- 2024: 3
- 2025: 5
- 2026: 5

## Most-cited predicates
- K063778: Force Fiber Polyethylene Nonabsorbable Suture (2007), cited by 17
- K980155: Endobutton Continuous Loop (1998), cited by 14
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture (2002), cited by 12
- K021434: Arthrex Fiberwire in Usp Sizes (2002), cited by 11
- K122374: Arthrex Suture (Uhmwpe) (2012), cited by 10
- K041553: Arthrex Suture Grafting Kit (2004), cited by 10
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures (2009), cited by 10
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need (2010), cited by 9
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N (2012), cited by 8
- K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK (2010), cited by 8

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