# K252820: PGLA90 Poly (glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly (glycolide-co-L-lactide) Surgical Sutures (Odysseus)

- Pathway: 510(k) (Special)
- Applicant: Internacional Farmacéutica S.A DE C.V
- Decided: Oct 3, 2025 after 29 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: 2 generations back to K022269 (2002). 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)
- K072859: Atramat PGLA90 Poly (Glycolide-CO-L-Lactide) Surgical Sutures, Internacional Farmaceutica, S.A. DE C.V. (2008) Summary page 5.

## Indications for use
Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Source page: https://510kreport.com/device/K252820
Methodology: https://510kreport.com/methodology