# K072859: Atramat PGLA90 Poly (Glycolide-CO-L-Lactide) Surgical Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Internacional Farmaceutica, S.A. DE C.V.
- Decided: May 23, 2008 after 231 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 K022269 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.
- K022715: Coated Vicryl Plus Antimicrobial (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.

## Most influential descendants
- K252820: PGLA90 Poly (glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly (glycolide-co-L-lactide) Surgical Sutures (Odysseus) (2025), 0 descendants of its own

## 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/K072859
Methodology: https://510kreport.com/methodology