# K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties Corp
- Decided: Aug 3, 2007 after 10 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: 6 generations back to K014153 (2002). 24 ancestors in all.
26 later devices descend from it; 5 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051609: Quill Synthetic Absorbable Barbed Suture, Quill Medical, Inc. (2005) Summary page 1.
- K052437: Modified Monoderm Monofilament, Synthetic, Absorbable Suture, Surgical Specialties Corp (2005) Summary page 1.
- K964072: Monocryl (Poliglecaprone 25) Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K123836: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), 11 descendants of its own
- K141778: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2014), 10 descendants of its own

## Indications for use
QuillTM Self-Retaining System (SRS) comprised of MONODERMTM is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K072028
Methodology: https://510kreport.com/methodology