# K253530: Trexon™ Monofilament Synthetic Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: May 28, 2026 after 196 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000037 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000037: Monofilament Biosyn Suture, United States Surgical, A Division of Tyco Healthc (2000) Summary page 5.

## Indications for use
Trexon™ Monofilament Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological surgery.

Source page: https://510kreport.com/device/K253530
Methodology: https://510kreport.com/methodology