510(k) · Cleared
ClearedQuill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corp · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Aug 6, 2007 as substantially equivalent to K051609 (Quill Medical, Inc., 2005) after a 17-day review. Its family tree reaches back 6 generations to 2002. 31 later devices descend from it.
- Decided
- Aug 6, 2007
- Review
- 17 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K014153 (2002). 15 ancestors in all, the oldest K915489 (1992). 31 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 5 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 4 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 3 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 2 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 1 generation backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- This deviceK071989 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 · 2 generations on · 13 of its ownK120827 Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech · 2012
- Descendant · 3 generations on · 8 of its ownK150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015
- Descendant · 4 generations on · 7 of its ownK182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices…ETHICON, Inc. · 2019 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- 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
- K120827Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech · 2012 · 2 generations on13descendants
- K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015 · 3 generations on8descendants
- K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc. · 2019 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −5 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −4 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −3 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −2 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −1 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | K120827 | Quill Pdo Knotless Tissue-Closure Device (Polydixanone) | Angiotech | 2012 | — |
| +3 | K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015 | — |
| +4 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral… | ETHICON, Inc. | 2019 | 5 |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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? (2)
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…T equivalent to the following predicate device: - Quill TM Synthetic Absorbable Polydioxanone Barbed Suture by Quill Medical, Inc., 5 10(k) K051609 * PDS II Synthetic Absorbable Surgical Suture by Ethicon, Inc. Docket no. 99P- 5589. 4. Device Description:… | 2005 |
| * | — | PDS II Synthetic Absorbable Surgical Suture Named without a submission number |
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K080680 (Surgical Specialties Corp, 2008) has gone furthest, with 30 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. 2007, 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?
Quill TM Self-Retaining System (SRS) comprised of PDO 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/K071989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071989: Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071989
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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