510(k) · Cleared
ClearedY.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Y. Jacobs Medical, Inc. · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Nov 23, 2016 as substantially equivalent to K080985 (Surgical Specialties Corp, 2008) and 3 other predicates after a 254-day review. Its family tree reaches back 10 generations to 2002.
- Decided
- Nov 23, 2016
- Review
- 254 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K014153 (2002). 24 ancestors in all, the oldest K915489 (1992). No later device cites it as a predicate yet.
- Root · 10 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 6 generations between
- 3 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 2 generations backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- 1 generation backK130191 MINTHans Biomed Corporation · 2013
- This deviceK160705 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. · 2016
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 backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 3 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 2 generations backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- 1 generation backK130191 MINTHans Biomed Corporation · 2013
- This deviceK160705 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. · 2016
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 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| −3 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
| −2 | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | 2008 | — |
| −1 | K130191 | MINT | Hans Biomed Corporation | 2013 | — |
| 0 (this device) | K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, | Y. Jacobs Medical, Inc. | 2016 | — |
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 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 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 |
|---|---|---|---|
| * | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Summary page 5…and predicates: Indications for Use Materials of manufacture Table 5-1 Primary Predicate Device 510k Number Trade or Proprietary or Model Name Manufacturer K080985 QuillTM Self-Retaining System (SRS) Surgical Specialties Corp. Table 5-2 Additional Predicate Device 510k Number Trade… | 2008 |
| * | K130191 | MINTSummary page 5…Self-Retaining System (SRS) Surgical Specialties Corp. Table 5-2 Additional Predicate Device 510k Number Trade or Proprietary or Model Name Manufacturer K130191 MINTTM Hansbiomed Corp. K031216 MonoPlus Poly-p-dioxanone… | 2013 |
| * | K031216 | Monoplus Poly-P-Dioxanone Monofilament Absorbable Surgical SutureSummary page 5…redicate Device 510k Number Trade or Proprietary or Model Name Manufacturer K130191 MINTTM Hansbiomed Corp. K031216 MonoPlus Poly-p-dioxanone Aesculap, Inc. absorbable suture K123877 Quill™ P… | 2003 |
| * | K123877 | Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSummary page 5…TM Hansbiomed Corp. K031216 MonoPlus Poly-p-dioxanone Aesculap, Inc. absorbable suture K123877 Quill™ PDO Knotless-Tissue Closure Angiotech Device, Variable Loop Performance Data The data… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 5 of the 24 ancestors have a recall of any class.
- 6 other devices also cite its predicate K080985.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Y. JACOBS YOUNG’S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160705: Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160705
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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