# K212810: MONOFIX PGCL, knotless wound closure device

- Pathway: 510(k) (Traditional)
- Applicant: Samyang Holdings Corp., Ltd.
- Decided: Aug 5, 2022 after 336 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: 12 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)
- K141778: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corporation (2014) Summary page 4.

## Indications for use
MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.

Source page: https://510kreport.com/device/K212810
Methodology: https://510kreport.com/methodology