510(k) · Cleared
Recalled · Class II · 2024PDS Plus Antibacterial Suture
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 Jul 14, 2006 as substantially equivalent to K032420 (ETHICON, Inc., 2003) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 1996. 21 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 14, 2006
- Review
- 91 days
- Class
- Class II
- Product code
- NEW
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 2 generations to K960653 (1996). 4 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996 · Recalled
- 1 generation backK050845 Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005 · Recalled
- This deviceK061037 PDS Plus Antibacterial SutureETHICON, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices…ETHICON, Inc. · 2019 · Recalled
- Descendant · cites it directly · 5 of its ownK100461 PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · Recalled
- Descendant · 3 generations on · 2 of its ownK221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK212380 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable…ETHICON, Inc. · 2022 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015 · cites it directly8descendants
- K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc. · 2019 · 2 generations on7descendants
- K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · cites it directly5descendants
- K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022 · 3 generations on2descendants
- K212380PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureETHICON, Inc. · 2022 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) | ETHICON, Inc. | 1996 | 2 |
| −1 | K050845 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2005 | 1 |
| 0 (this device) | K061037 | PDS Plus Antibacterial Suture | ETHICON, Inc. | 2006 | — |
| +1 | K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015 | — |
| +2 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral… | ETHICON, Inc. | 2019 | 5 |
| +1 | K100461 | PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut | Riverpoint Medical | 2010 | 1 |
| +3 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2022 | — |
| +1 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical… | ETHICON, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 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; 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 | K018331 | PDS II (Polydioxanone) Suture Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K032420 | Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable SutureSummary page 1…dioxanone) Antibacterial Suture Predicate Devices: PDS II*(Polydioxanone) Suture (N18331) VICRYL* Plus Antibacterial Suture (K032420) MONOCRYL* Plus Antibacterial Suture (K050845) Statement of Intended Use: PDS* Plus A… | 2003 |
| * | K050845 | Monocryl Plus Antibacterial SutureSummary page 1…PDS II*(Polydioxanone) Suture (N18331) VICRYL* Plus Antibacterial Suture (K032420) MONOCRYL* Plus Antibacterial Suture (K050845) Statement of Intended Use: PDS* Plus Antibacterial monofilament synthetic absorbable sutures are indic… | 2005 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | 2015 | 8 |
| K100461 | PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut | 2010 | 5 |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | 2022 | 2 |
| K113004 | PDS (TM) Barbed Sutures | 2011 | 1 |
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II… | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2024 | Class II | Z-2147-2024 | Under Investigation by firm | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| Mar 31, 2023 | Class II | Z-1571-2023 | Under Investigation by firm | Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved |
| Mar 12, 2019 | Class II | Z-1135-2019 | Packaging process control | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. |
| Jun 8, 2018 | Class II | Z-2533-2018 | Under Investigation by firm | Products do not meet a tensile strength specification |
| Jun 8, 2018 | Class II | Z-2532-2018 | Under Investigation by firm | Products do not meet a tensile strength specification |
| Jan 10, 2018 | Class II | Z-1340-2018 | Process control | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. |
| Jan 10, 2018 | Class II | Z-1338-2018 | Process control | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. |
| Jan 10, 2018 | Class II | Z-1339-2018 | Process control | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture. |
| Feb 2, 2009 | Not classified | Z-1314-2009 | Process control | Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 9.3 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K150670 (ETHICON, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K032420.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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* Plus Antibacterial monofilament synthetic absorbable sutures are indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS Plus is not indicated in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061037: PDS Plus Antibacterial Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061037
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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