# K122898: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties Corp. Dba Angiotech
- Decided: Oct 22, 2012 after 31 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K014153 (2002). 30 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113744: Quill Pdo Knotless Tissue-Closure Device (Polydioxanone), Angiotech (2012) Summary page 1.
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm, Surgical Specialties Corp (2007) Summary page 1.
- K100257: VLOC9ABSORBABLE Wound Closure Device, Surgical Devices, A Division of Tyco Healthcare (2010) Summary page 1.

## Most influential descendants
- 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
- K151200: STRATAFIX  Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (2015), 8 descendants of its own
- K182873: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices (2019), 7 descendants of its own

## Recalls of this device
- Mar 24, 2022 · Class II · Z-1053-2022: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

## Indications for use
Quill Knotless Tissue-Closure Device comprised of Monoderm is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K122898
Methodology: https://510kreport.com/methodology