# K191361: DemeDIOX Barbed Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corporation
- Decided: Nov 7, 2019 after 170 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113004: PDS (TM) Barbed Sutures, ETHICON, Inc. (2011) Summary page 4.
- K082097: Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture, Demetech Corp. (2010) Summary page 4.

## Indications for use
DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Source page: https://510kreport.com/device/K191361
Methodology: https://510kreport.com/methodology