# K040477: Monoderm

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties Corp
- Decided: May 18, 2004 after 84 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 K885018 (1989). 5 ancestors in all.
29 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930772: Ethicon* Monocryl (Poliglecaprone 25) Suture, ETHICON, Inc. (1994) Summary page 1.
- K013671: L-25 Absorbable Surigcal Suture, United States Surgical, A Division of Tyco Healthc (2002) Summary page 1.

## Most influential descendants
- K052437: Modified Monoderm Monofilament, Synthetic, Absorbable Suture (2005), 28 descendants of its own
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm (2007), 26 descendants of its own
- K100257: VLOC9ABSORBABLE Wound Closure Device (2010), 24 descendants of its own
- K122898: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), 19 descendants of its own
- K123409: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), 18 descendants of its own

## Indications for use
Monoderm sutures are 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/K040477
Methodology: https://510kreport.com/methodology