510(k) · Cleared
ClearedQuill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corp. Dba Angiotech · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Feb 28, 2013 as substantially equivalent to K052373 (Quill Medical, Inc., 2005) and 2 other predicates after a 45-day review. Its family tree reaches back 10 generations to 2002. 5 later devices descend from it.
- Decided
- Feb 28, 2013
- Review
- 45 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K014153 (2002). 33 ancestors in all, the oldest K885018 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 6 generations between
- 3 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 2 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 1 generation backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- This deviceK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
- Descendant · cites it directly · 2 of its ownK131224 Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical…Surgical Specialties Corp. Dba Angiotech · 2013
- Descendant · cites it directly · 1 of its ownK151112 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Angiotech · 2015
- Descendant · 2 generations on · 0 of its ownK253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control…ETHICON, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK233355 Cypris eXact Suturing SystemCypris Medical · 2024
- Descendant · 2 generations on · 0 of its ownK211178 DURAMESH Mesh SutureMsi · 2022
Show all 10 generations
- Root · 10 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 9 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 8 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 7 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 6 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 5 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 4 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- 3 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 2 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 1 generation backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- This deviceK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
Most influential descendants
Showing 5 of 5 · See all- K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech · 2013 · cites it directly2descendants
- K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech · 2015 · cites it directly1descendant
- K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc. · 2026 · 2 generations on0descendants
- K233355Cypris eXact Suturing SystemCypris Medical · 2024 · 2 generations on0descendants
- K211178DURAMESH Mesh SutureMsi · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −9 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −8 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −7 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −6 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −5 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −4 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| −3 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| −2 | K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | 1 |
| −1 | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| 0 (this device) | K130078 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2013 | — |
| +1 | K131224 | Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture… | Surgical Specialties Corp. Dba Angiotech | 2013 | — |
| +1 | K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Angiotech | 2015 | — |
| +2 | K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device… | ETHICON, Inc. | 2026 | — |
| +2 | K233355 | Cypris eXact Suturing System | Cypris Medical | 2024 | — |
| +2 | K211178 | DURAMESH Mesh Suture | Msi | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K052373 | Quill Nonabsorbable Polypropylene Barbed SutureSummary page 1…duct code, GAW 21 CFR 878.5010 Class 11 Legally marketed K052373 QuiITM Nonabsorbable Polypropylene Barbed devices to which the Suture… | 2005 |
| * | K113744 | Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Summary page 1…373 QuiITM Nonabsorbable Polypropylene Barbed devices to which the Suture device is substantially K1 13744: QuiITM PDO Knotless Tissue-Closure Device equivalent: (Polydioxanone)… | 2012 |
| * | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 1…less Tissue-Closure Device equivalent: (Polydioxanone), Variable Loop Design K123409: QuiITM MonoderMmM Knotless Tissue-Closure Device, Varia… | 2012 |
What descends from it? (5)
2 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 11 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 12 of the 33 ancestors have a recall of any class.
- Of its descendants, K131224 (Surgical Specialties Corp. Dba Angiotech, 2013) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K052373.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
QuiITM Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130078: Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130078
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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