# OWY: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 111 days (middle half 78–149)
- 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)
- 2012: 1
- 2013: 2
- 2014: 1
- 2016: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 4

## Most-cited predicates
- K201572: TAPESTRY Biointegrative Implant (2020), cited by 3
- K151083: BioBridge Collagen Matrix (2016), cited by 2
- K222501: Regeneten Bioinductive Implant (2023), cited by 2
- K212306: Tapestry Biointegrative Implant (2021), cited by 2
- K140300: Collagen Tendon Sheet-Ddi (CTS-Ddi) (2014), cited by 1
- K131143: Trellis Collagen Ribbon (2013), cited by 1

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