# K141778: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design

- Pathway: 510(k) (Special)
- Applicant: Surgical Specialties Corporation
- Decided: Jul 30, 2014 after 28 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: 11 generations back to K014153 (2002). 33 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122898: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corp. Dba Angiotech (2012) Summary page 1.
- K123409: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corp. Dba Angiotech (2012) Summary page 1.
- K123836: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corp. Dba Angiotech (2012) Summary page 1.

## Most influential descendants
- 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
- K221744: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (2022), 2 descendants of its own
- K232246: 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture (2024), 1 descendant of its own
- K192144: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (2020), 1 descendant of its own

## Indications for use
Quill™ MONODERM™ Knotless Tissue-Closure Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

Source page: https://510kreport.com/device/K141778
Methodology: https://510kreport.com/methodology