510(k) · Cleared
Recalled · Class II · 2013PDS (TM) Barbed Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Dec 20, 2011 as substantially equivalent to K061037 (ETHICON, Inc., 2006) and 1 other predicate after a 74-day review. Its family tree reaches back 9 generations to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 20, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- NEW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K014153 (2002). 23 ancestors in all, the oldest K915489 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 5 generations between
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK113004 PDS (TM) Barbed SuturesETHICON, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK191361 DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation · 2019
Show all 9 generations
- Root · 9 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 8 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 7 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 6 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 5 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 4 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 3 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 2 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 1 generation backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- This deviceK113004 PDS (TM) Barbed SuturesETHICON, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −8 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −7 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −6 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −5 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −4 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −3 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| −2 | 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 | — |
| 0 (this device) | K113004 | PDS (TM) Barbed Sutures | ETHICON, Inc. | 2011 | — |
| +1 | K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 |
|---|---|---|---|
| * | K061037 | PDS Plus Antibacterial SutureSummary page 1…ct Code: NEW Predicate Devices: PDS IITM (polydioxanone) Suture (N18331) PDSTM Plus Antibacterial (polydioxanone) Suture (K06 1037) Quil TM Self-Retaining System (SRS) (K080985) Manufacturer: Ethicon Inc.… | 2006 |
| * | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Summary page 1…N18331) PDSTM Plus Antibacterial (polydioxanone) Suture (K06 1037) Quil TM Self-Retaining System (SRS) (K080985) Manufacturer: Ethicon Inc. P.O. Box 151 R… | 2008 |
| * | — | PDS II (polydioxanone) Suture Named without a submission number | |
| † | K091087 | Modification to V-Loc 180 Absorbable Wound Closure Device | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2013 | Class II | Z-0458-2014 | Unknown/Undetermined by firm | Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 9 of the 23 ancestors have a recall of any class.
- Of its descendants, K191361 (Demetech Corporation, 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K061037.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113004: PDS (TM) Barbed Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113004
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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