510(k) · Cleared
ClearedSharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure
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 May 16, 2013 as substantially equivalent to K904906 (Chathamborough Research Group, Inc., 1990) and 6 other predicates after a 16-day review. Its family tree reaches back 11 generations to 2002. 2 later devices descend from it.
- Decided
- May 16, 2013
- Review
- 16 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 11 generations to K014153 (2002). 39 ancestors in all, the oldest K885018 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 7 generations between
- 3 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 2 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
- This deviceK131224 Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical…Surgical Specialties Corp. Dba Angiotech · 2013
- Descendant · cites it directly · 0 of its ownK233355 Cypris eXact Suturing SystemCypris Medical · 2024
- Descendant · cites it directly · 0 of its ownK211178 DURAMESH Mesh SutureMsi · 2022
Show all 11 generations
- Root · 11 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 10 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 9 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 8 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 7 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 6 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 5 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- 4 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 3 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 2 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
- This deviceK131224 Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical…Surgical Specialties Corp. Dba Angiotech · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −10 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −9 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −8 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −7 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −6 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −5 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| −4 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| −3 | K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | 1 |
| −2 | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| −1 | K130078 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2013 | — |
| 0 (this device) | K131224 | Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture… | Surgical Specialties Corp. Dba Angiotech | 2013 | — |
| +1 | K233355 | Cypris eXact Suturing System | Cypris Medical | 2024 | — |
| +1 | K211178 | DURAMESH Mesh Suture | Msi | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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? (8)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P870064 | Sharpoint Polypropylene Nonabsorbable Surgical Suture Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ylene surgical suture Product code, GAW 21 CER 878.5010 Class 11 Legally marketed P870064 Sharpoint Polypropylene Nonabsorbable devices to which the K904906 Surgical Suture device is substantial… | |
| * | K904906 | Sharpoint Polypropylene Nonabsorb Surg Sutures UspSummary page 1…21 CER 878.5010 Class 11 Legally marketed P870064 Sharpoint Polypropylene Nonabsorbable devices to which the K904906 Surgical Suture device is substantially K930825 equivalent: K903584 Look Inc. Pol… | 1990 |
| * | K930825 | Suture Nonabsorbable-Nylon,Silk,Polyester,StainlesSummary page 1…Legally marketed P870064 Sharpoint Polypropylene Nonabsorbable devices to which the K904906 Surgical Suture device is substantially K930825 equivalent: K903584 Look Inc. Polypropylene Nonabsorbable K926588… | 1994 |
| * | K903584 | Polypropylene Nonabsorbable Surgical SuturesSummary page 1…Sharpoint Polypropylene Nonabsorbable devices to which the K904906 Surgical Suture device is substantially K930825 equivalent: K903584 Look Inc. Polypropylene Nonabsorbable K926588 Surgical Sutures… | 1990 |
| * | K926588 | Revised Labeling for Polypropylene SutureSummary page 1…Surgical Suture device is substantially K930825 equivalent: K903584 Look Inc. Polypropylene Nonabsorbable K926588 Surgical Sutures K052373 QUiITm Nonabsorbable Polypropylene Barbed… | 1993 |
| * | K052373 | Quill Nonabsorbable Polypropylene Barbed SutureSummary page 1…K903584 Look Inc. Polypropylene Nonabsorbable K926588 Surgical Sutures K052373 QUiITm Nonabsorbable Polypropylene Barbed K113800 Suture… | 2005 |
| * | K113800 | Quill Quadrahelix Tissue-Closure DeviceSummary page 1…K926588 Surgical Sutures K052373 QUiITm Nonabsorbable Polypropylene Barbed K113800 Suture K 130078 Description of the The Polypropylene Surgical Suture and… | 2012 |
| * | K130078 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSummary page 1…tures K052373 QUiITm Nonabsorbable Polypropylene Barbed K113800 Suture K 130078 Description of the The Polypropylene Surgical Suture and Quil TM Polypropylene device: Knotles… | 2013 |
What descends from it? (2)
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 9 months on median.
- 14 of the 39 ancestors have a recall of any class.
- Of its descendants, K233355 (Cypris Medical, 2024) has gone furthest, with 0 descendants of its own.
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?
Polypropylene Suture is indicated for use in general soft tissue approxination and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Quill™ 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/K131224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131224: Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131224
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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