# K252171: Barbed PDO Suture

- Pathway: 510(k) (Traditional)
- Applicant: Sutura Medical Technology, Inc.
- Decided: Jun 12, 2026 after 337 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: 3 generations back to K142061 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192423: MINT Product Family, Hans Biomed Corporation (2020) Summary page 5.

## Indications for use
The Barbed PDO Suture is indicated for placement in the subcutaneous plane for temporary fixation of the cheek adipose layer in midface suspension surgery.

Source page: https://510kreport.com/device/K252171
Methodology: https://510kreport.com/methodology