# K120827: Quill Pdo Knotless Tissue-Closure Device (Polydixanone)

- Pathway: 510(k) (Traditional)
- Applicant: Angiotech
- Decided: Jul 13, 2012 after 116 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K014153 (2002). 18 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 32 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.
- K080680: Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone, Surgical Specialties Corp (2008) Summary page 1.
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo), Surgical Specialties Corp (2008) Summary page 1.
- (no number) Ethicon PDS II (Polydioxanone) Sutures: named in the summary without a submission number

## Most influential descendants
- K150670: STRATAFIX Spiral PDS 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
QUiIITM PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K120827
Methodology: https://510kreport.com/methodology