# K041048: Polydioxanone Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Internacional Farmaceutica, S.A. DE C.V.
- Decided: Jun 4, 2004 after 43 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P018331: PDS II Polydioxanone Synthetic Absorbable Polydioxanone Surgical Sutures. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Atramat ® Synthetic Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Atramat @ Synthetic Absorbable Polydioxanone Surgical Sutures are not indicated for use in adult cardiovascular, microsurgical, and neuro surgery uses.

Source page: https://510kreport.com/device/K041048
Methodology: https://510kreport.com/methodology