# OWW: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 95 days (middle half 54–138)
- 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
- 2016: 1
- 2021: 1
- 2023: 2
- 2024: 3
- 2025: 2

## Most-cited predicates
- K203267: The BioBrace Implant (2021), cited by 2
- K230316: FlexBand; FlexPatch; FlexBand Plus (2023), cited by 2
- K241906: BioBrace®  Reinforced Implant (2024), cited by 2
- K242187: BioBrace® (2024), cited by 1
- K240817: VersaWrap (2024), cited by 1
- K160364: VersaWrap Tendon Protector (2016), cited by 1
- K121216: STR Graft (2012), cited by 1

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