510(k) · Cleared
ClearedQuill Synthetic Absorbable Barbed Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quill Medical, Inc. · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Aug 4, 2005 as substantially equivalent to K042075 (Quill Medical, Inc., 2004) and 3 other predicates after a 48-day review. Its family tree reaches back 5 generations to 2002. 64 later devices descend from it.
- Decided
- Aug 4, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K014153 (2002). 14 ancestors in all, the oldest K915489 (1992). 64 later devices descend from it, 11 citing it directly.
- Root · 5 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 4 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 3 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 2 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 1 generation backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- This deviceK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- Descendant · cites it directly · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- Descendant · cites it directly · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- Descendant · cites it directly · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- Descendant · cites it directly · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- Descendant · cites it directly · 25 of its ownK113744 Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech · 2012
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · cites it directly31descendants
- K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · cites it directly30descendants
- K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · cites it directly29descendants
- K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · cites it directly26descendants
- K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech · 2012 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −4 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −3 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −2 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −1 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| 0 (this device) | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| +1 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| +1 | 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 | — |
| +1 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| +1 | K113744 | Quill Pdo Knotless Tissue-Closure Device (Polydioxanone) | Angiotech | 2012 | — |
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 |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K042075 | Quill Synthetic Absorbable Barbed SutureSummary page 1…following predicate devices: * For Material Safety and Technological Characteristics: *Quill® Synthetic Absorbable Barbed Suture,510k K042075 *Contour Midface Opposing Uni-directional Thread by Surgical Specialties Corp., K050548… | 2004 |
| * | K050548 | Contour Midface Opposing Uni-Directional ThreadsSummary page 1…*Quill® Synthetic Absorbable Barbed Suture,510k K042075 *Contour Midface Opposing Uni-directional Thread by Surgical Specialties Corp., K050548 *Insorb T m Absorbable Staple by Incisive Surgical, Inc., 5 10k K024 117 * For Indication for Use:… | 2005 |
| * | K024117 | Insorb Absorbable Staples, Model SP-B20Summary page 1…ce Opposing Uni-directional Thread by Surgical Specialties Corp., K050548 *Insorb T m Absorbable Staple by Incisive Surgical, Inc., 5 10k K024 117 * For Indication for Use: *Y-Knot Suture Clip by Innovasive Device, Inc., 510k K973313… | 2003 |
| * | K973313 | Innovasive Devices Y-Knot Suture ClipSummary page 1…m Absorbable Staple by Incisive Surgical, Inc., 5 10k K024 117 * For Indication for Use: *Y-Knot Suture Clip by Innovasive Device, Inc., 510k K973313 *Insorb Tm Absorbable Staple by Incisive Surgical, Inc., 5 10k K0241 17 P04-06a (8-2-05) QUill TM Synthetic Ab… | 1997 |
| † | K041593 | Featherlift Extended Length Aptos Thread | 2004 |
| † | K915489 | Auto Suture Absorable Subcuticular Closure Staple | 1992 |
| † | K915693 | Proximate Absorbable Staples | 1992 |
What descends from it? (64)
See all 6411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | 2007 | 31 |
| K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | 2008 | 30 |
| K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | 2008 | 29 |
| K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | 2007 | 26 |
| K113744 | Quill Pdo Knotless Tissue-Closure Device (Polydioxanone) | 2012 | 25 |
| K120827 | Quill Pdo Knotless Tissue-Closure Device (Polydixanone) | 2012 | 13 |
| K052373 | Quill Nonabsorbable Polypropylene Barbed Suture | 2005 | 10 |
| K133420 | Tranquill Barbed Device | 2013 | 6 |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | 2018 | 3 |
| K053380 | Contour Thread Synthetic Absorbable Pdo Barbed Suture | 2006 | 3 |
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 3 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K071989 (Surgical Specialties Corp, 2007) has gone furthest, with 31 descendants of its own.
- 3 other devices also cite its predicate K042075.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051609 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051609: Quill Synthetic Absorbable Barbed Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051609
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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