# K140227: Monoderm Surgical Suture

- Pathway: 510(k) (Special)
- Applicant: Surgical Specialties Corp
- Decided: Feb 28, 2014 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: 4 generations back to K885018 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052437: Modified Monoderm Monofilament, Synthetic, Absorbable Suture, Surgical Specialties Corp (2005) Summary page 1.

## Indications for use
MONODERM (PGA-PCL) suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K140227
Methodology: https://510kreport.com/methodology