510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Monodek Synthetic Absorbable Surgical Suture

K030212510(k) TraditionalCleared Mar 27, 200365-day reviewClass II21 CFR 878.4840Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genzyme Biosurgery · NEW Suture, Surgical, Absorbable, Polydioxanone

Cleared on Mar 27, 2003 as substantially equivalent to K013274 (Cp Medical, 2001) after a 65-day review. Its family tree reaches back 1 generation to 2001. 12 later devices descend from it. It has been recalled 3 times.

Decided
Mar 27, 2003
Review
65 days
Class
Class II
Product code
NEW
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K013274 (2001). 12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2012: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 4 descendants cleared2021: 1 descendant cleared2025: 1 descendant cleared2024: 2 descendants clearedK013274 · Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile · Cp Medical · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K013274 · Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile · Cp Medical · 2001 · recalled0
  1. Root · 1 generation backK013274 Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical · 2001 · Recalled
  2. This deviceK030212 Monodek Synthetic Absorbable Surgical SutureGenzyme Biosurgery · 2003
  3. Descendant · cites it directly · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
  4. Descendant · 2 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
  5. Descendant · 2 generations on · 2 of its ownK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
  6. Descendant · 3 generations on · 1 of its ownK242201 HyperSuture White/Green Extension LineThreadstone, LLC · 2025
  7. Descendant · 3 generations on · 1 of its ownK210675 EasyWhipWinter Innovations, Inc. · 2021

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2012: 12018: 12019: 12021: 12023: 12024: 22025: 12026: 4
2012high 4 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 12 · See all
  • K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · cites it directly10descendants
  • K230311HyperSutureThreadstone, LLC · 2023 · 2 generations on4descendants
  • K191268Force Fiber SutureTeleflex Medical Incorporated · 2019 · 2 generations on2descendants
  • K242201HyperSuture White/Green Extension LineThreadstone, LLC · 2025 · 3 generations on1descendant
  • K210675EasyWhipWinter Innovations, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013274Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical20013
0 (this device)K030212Monodek Synthetic Absorbable Surgical SutureGenzyme Biosurgery2003—
+1K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures…Teleflex Medical Incorporated2018—
+2K230311HyperSutureThreadstone, LLC2023—
+2K191268Force Fiber SutureTeleflex Medical Incorporated2019—
+3K242201HyperSuture White/Green Extension LineThreadstone, LLC2025—
+3K210675EasyWhipWinter Innovations, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201810
201910
202110
202310
202420
202510
202640
FIG. 1 — Lineage of K030212, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013274Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical20013
*—Ethicon PDS II Absorbable Surgical Suture
Named without a submission number
—

Also cleared against K013274: 2 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810
K120284Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with…Coloplast A/S20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2014Class IIZ-1534-2014OtherThe product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
Mar 11, 2014Class IIZ-1509-2014Under Investigation by firmProduct does not meet minimum knot tensile strength requirements.
Jun 6, 2007Not classifiedZ-1016-2007OtherThe products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K181774 (Teleflex Medical Incorporated, 2018) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K013274.

How does its category compare?

All NEW devices

NEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEW

6in 2025

2007: 22008: 52010: 32011: 12012: 32013: 52014: 12015: 22016: 32017: 12018: 32019: 42020: 32021: 12022: 12023: 12024: 32025: 62026 (partial year): 5
2007high 6 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEW

146in 2025

2008: 22 days median2010: 270 days median2012: 113 days median2013: 32 days median2016: 254 days median2018: 441 days median2019: 144 days median2020: 230 days median2024: 48 days median2025: 146 days median2026 (partial year): 264 days median
2007high 441 (2018) · low 22 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NEW

1in 2022

2008: 12009: 42012: 12013: 12014: 12019: 22022: 1
2007high 4 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NEW

2,504in 2025

2007: 72008: 292009: 422010: 1152011: 592012: 822013: 1852014: 2742015: 2802016: 3212017: 4612018: 9002019: 1,1222020: 1,0102021: 1,4662022: 1,5372023: 1,9752024: 2,1142025: 2,504
2007high 2,504 (2025) · low 7 (2007)2025

MAUDE reports naming product code NEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—07
2008522129
20090—442
201032700115
20111—059
20123113182
20135321185
20141—1274
20152—0280
201632540321
20171—0461
201834410900
2019414421,122
2020323001,010
20211—01,466
20221—11,537
20231—01,975
202434802,114
2025614602,504
202652640—

What is it indicated for?

MonodekTM Synthetic Absorbable Surgical 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 opthalmic surgery. 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.

Also cleared against K013274

2 other devices cite the same predicate.

  • K082097Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureDemetech Corp. · 2010
  • K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003

More from Genzyme Biosurgery

19 FDA decisions under this applicant name. See the company

Recent decisions in NEW

The NEW category page

  • K254238MINT MONO SuturesHans Biomed Corporation · 2026
  • K253879Monofix PdoSamyang Holdings Corporation · 2026
  • K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC · 2026
  • K252171Barbed PDO SutureSutura Medical Technology, Inc. · 2026
  • K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc. · 2026

https://510kreport.com/device/K030212 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030212: Monodek 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/K030212

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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