510(k) · Cleared
Recalled · 2009Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Nov 16, 2001 after a 46-day review. The FDA summary names its predicate without a number. 26 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 16, 2001
- Review
- 46 days
- Class
- Class II
- Product code
- NEW
- Recalls
- 3
- Predicates
- 0
26 later devices descend from it, 3 citing it directly.
- This deviceK013274 Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical · 2001
- Descendant · cites it directly · 12 of its ownK030212 Monodek Synthetic Absorbable Surgical SutureGenzyme Biosurgery · 2003 · Recalled
- Descendant · 2 generations on · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- Descendant · cites it directly · 7 of its ownK031443 Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003
- Descendant · 2 generations on · 5 of its ownK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
- Descendant · 3 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K030212Monodek Synthetic Absorbable Surgical SutureGenzyme Biosurgery · 2003 · cites it directly12descendants
- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · 2 generations on10descendants
- K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003 · cites it directly7descendants
- K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc. · 2010 · 2 generations on5descendants
- K230311HyperSutureThreadstone, LLC · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013274 | Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile | Cp Medical | 2001 | — |
| +1 | K030212 | Monodek Synthetic Absorbable Surgical Suture | Genzyme Biosurgery | 2003 | 3 |
| +2 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +1 | K031443 | Lsi Solutions Suture Quick Load Products | Lsi Solutions | 2003 | — |
| +2 | K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | Lsi Solutions, Inc. | 2010 | — |
| +3 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | — | PDS II, Synthetic Absorbable Polydioxanone Surgical Sutures Named without a submission number |
What descends from it? (26)
See all 263 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2009 | Not classified | Z-0259-2012 | Nonconforming Material/Component | The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch. |
| Sep 17, 2008 | Not classified | Z-2582-2010 | Vendor change control | Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised. |
| Apr 3, 2007 | Not classified | Z-0809-2007 | Other | Potential for sterility of product to be compromised. Suture package seals incomplete or missing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030212 (Genzyme Biosurgery, 2003) has gone furthest, with 12 descendants of its own.
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?
Mono-Dox, Monofilament Synthetic Absorbable Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.
Mono-Dox suture is not indicated for use in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013274: Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026