# K253879: Monofix Pdo

- Pathway: 510(k) (Traditional)
- Applicant: Samyang Holdings Corporation
- Decided: Aug 25, 2026 after 264 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K014153 (2002). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120827: Quill Pdo Knotless Tissue-Closure Device (Polydixanone), Angiotech (2012) Summary page 5.

## Indications for use
MONOFIX PDO absorbable knotless wound closure device is indicated for soft tissue approximation where the use of absorbable sutures is appropriate.

Source page: https://510kreport.com/device/K253879
Methodology: https://510kreport.com/methodology