510(k) · Cleared
ClearedQuill Pdo Knotless Tissue-Closure Device (Polydixanone)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angiotech · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Jul 13, 2012 as substantially equivalent to K051609 (Quill Medical, Inc., 2005) and 2 other predicates after a 116-day review. Its family tree reaches back 9 generations to 2002. 13 later devices descend from it.
- Decided
- Jul 13, 2012
- Review
- 116 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K014153 (2002). 18 ancestors in all, the oldest K915489 (1992). 13 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 5 generations between
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK120827 Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech · 2012
- Descendant · cites it directly · 8 of its ownK150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices…ETHICON, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 2 of its ownK221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK232246 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone)…M/s. Meril Endo Surgery Private Limited. · 2024
- Descendant · cites it directly · 1 of its ownK192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. · 2020 · Recalled
Show all 9 generations
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 8 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 7 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 6 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 5 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 4 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK120827 Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015 · cites it directly8descendants
- K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc. · 2019 · 2 generations on7descendants
- K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022 · 3 generations on2descendants
- K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited. · 2024 · 3 generations on1descendant
- K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −8 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −7 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −6 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −5 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −4 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −3 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| −2 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
| −1 | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | 2008 | — |
| 0 (this device) | K120827 | Quill Pdo Knotless Tissue-Closure Device (Polydixanone) | Angiotech | 2012 | — |
| +1 | K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015 | — |
| +2 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral… | ETHICON, Inc. | 2019 | 5 |
| +3 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2022 | — |
| +3 | K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless… | M/s. Meril Endo Surgery Private Limited. | 2024 | — |
| +1 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051609 | Quill Synthetic Absorbable Barbed SutureSummary page 1…anone Surgical Suture Product code, NEW 21 CFR 878.4840 Class 11 Legally marketed K05 1609 Quilt Synthetic Absorbable Barbed Suture devices to which the K080680 device is substantially K080985 equivalent… | 2005 |
| * | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSummary page 1…21 CFR 878.4840 Class 11 Legally marketed K05 1609 Quilt Synthetic Absorbable Barbed Suture devices to which the K080680 device is substantially K080985 equivalent: N18331 Ethicon PDS IITM (Polydioxanone) Sutures Descript… | 2008 |
| * | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Summary page 1…Class 11 Legally marketed K05 1609 Quilt Synthetic Absorbable Barbed Suture devices to which the K080680 device is substantially K080985 equivalent: N18331 Ethicon PDS IITM (Polydioxanone) Sutures Description of the The QuiIITM Knot… | 2008 |
| * | — | Ethicon PDS II (Polydioxanone) Sutures Named without a submission number |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | 2015 | 8 |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | 2020 | 1 |
| K253879 | Monofix Pdo | 2026 | 0 |
| K210871 | PDO Max Suture with Dual Needle | 2021 | 0 |
| K201139 | WEGO-PDO Barbed Suture | 2020 | 0 |
| K143413 | J+PRAS YOUNG'S Thread | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K150670 (ETHICON, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 10 other devices also cite its predicate K051609.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
QUiIITM PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120827: Quill Pdo Knotless Tissue-Closure Device (Polydixanone).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120827
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026