# QUW: Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 90 days (middle half 73–220)
- 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)
- 2022: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), cited by 3
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), cited by 2
- K261621: TekBrace Solo Soft Tissue Reinforcement Device (2026), cited by 1

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