# OWX: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 213 days (middle half 171–235)
- 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)
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K223538: Integrity Implant (2023), cited by 1
- K241219: FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (2024), cited by 1

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