510(k) · Cleared
ClearedMonodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical, LLC · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Jul 9, 2026 as substantially equivalent to K181774 (Teleflex Medical Incorporated, 2018) after a 27-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Jul 9, 2026
- Review
- 27 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K990088 (1999). 37 ancestors in all, the oldest K885018 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 6 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 5 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 4 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- 3 generations backK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
- 2 generations backK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
- 1 generation backK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- This deviceK261988 Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic…Teleflex Medical, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −6 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −5 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −4 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| −3 | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | Beere Precision Medical Instruments, Kmedic, Telef | 2009 | — |
| −2 | K150438 | Force Fiber OrthoTape suture | Teleflexmedical, Inc. | 2015 | — |
| −1 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| 0 (this device) | K261988 | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable… | Teleflex Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Summary page 5…Predicate Trade Name (Primary Predicate is listed first) Predicate Product Code(s) K181774 Force Fiber White and White/Blue, White/Black, Blue, and GAT, GAM, NEW White/Green suture… | 2018 |
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 27 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 15 of the 37 ancestors have a recall of any class.
- 3 other devices also cite its predicate K181774.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
MONODEK™ Sutures are indicated for use in all types of soft tissue approximation. MONODEK™ suture 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/K261988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261988: Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261988
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026