# NEW: Suture, Surgical, Absorbable, Polydioxanone

- Device class: 2; regulation: 21 CFR 878.4840; FDA's rule: 510(k) required
- FDA decisions: 67
- 510(k) review time 2021–2025: median 185 days (middle half 44–272)
- Recalls: 11 (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: 1
- 2018: 3
- 2019: 4
- 2020: 3
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 3
- 2025: 6
- 2026: 5

## Most-cited predicates
- K051609: Quill Synthetic Absorbable Barbed Suture (2005), cited by 11
- K040004: Orthocord Suture (2004), cited by 10
- K113744: Quill Pdo Knotless Tissue-Closure Device (Polydioxanone) (2012), cited by 7
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) (2008), cited by 7
- K120827: Quill Pdo Knotless Tissue-Closure Device (Polydixanone) (2012), cited by 6
- K182873: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices (2019), cited by 6
- K061037: PDS Plus Antibacterial Suture (2006), cited by 5
- K043298: Blue Orthocord Suture (2004), cited by 5
- K130191: MINT (2013), cited by 4
- K042075: Quill Synthetic Absorbable Barbed Suture (2004), cited by 4

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