# K173779: Rexmono, Pdrex

- Pathway: 510(k) (Traditional)
- Applicant: Sm Eng Co., Ltd.
- Decided: Mar 12, 2018 after 90 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: 8 generations back to K014153 (2002). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142810: WEGO-PGCL Absorbable Surgical Monofilament Suture, Foosin Medical Supplies Inc., Ltd. (2014) Summary page 6.
- K073614: WG-Surgical Sutures with Needle, Foosin Medical Supplies, Inc. (2008) Summary page 6.

## Indications for use
REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.

Source page: https://510kreport.com/device/K173779
Methodology: https://510kreport.com/methodology