510(k) Report

510(k) · Cleared

Recalled · 2009

Monocryl Plus Antibacterial Suture

K050845510(k) TraditionalCleared Jun 29, 200586-day reviewClass II21 CFR 878.4493Recalls 1

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

ETHICON, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Jun 29, 2005 as substantially equivalent to K960653 (ETHICON, Inc., 1996) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1996. 25 later devices descend from it. It has been recalled once.

Decided
Jun 29, 2005
Review
86 days
Class
Class II
Product code
GAM
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K960653 (1996). 3 ancestors in all. 25 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1996: 1 other ancestor2020: 2 descendants cleared2015: 2 descendants cleared2006: 1 descendant cleared2022: 2 descendants cleared2010: 1 descendant cleared2019: 4 descendants cleared2011: 1 descendant cleared2024: 2 descendants cleared2026: 2 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2025: 4 descendants cleared2018: 1 descendant clearedK960653 · Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) · ETHICON, Inc. · 1996 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 11 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K960653 · Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) · ETHICON, Inc. · 1996 · recalled0+5
  1. Root · 1 generation backK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996 · Recalled
  2. This deviceK050845 Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005
  3. Descendant · cites it directly · 21 of its ownK061037 PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · Recalled
  4. Descendant · cites it directly · 8 of its ownK151200 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX…ETHICON, Inc. · 2015 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015
  6. Descendant · 2 generations on · 7 of its ownK182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices…ETHICON, Inc. · 2019 · Recalled
  7. Descendant · 2 generations on · 5 of its ownK100461 PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · Recalled

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2006: 12010: 12011: 12013: 12014: 22015: 22018: 12019: 42020: 22022: 22024: 22025: 42026: 2
2006high 4 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 25 · See all
  • K061037PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · cites it directly21descendants
  • K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc. · 2015 · cites it directly8descendants
  • K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015 · 2 generations on8descendants
  • 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 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960653Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc.19962
0 (this device)K050845Monocryl Plus Antibacterial SutureETHICON, Inc.2005—
+1K061037PDS Plus Antibacterial SutureETHICON, Inc.20069
+1K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral…ETHICON, Inc.20151
+2K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc.2015—
+2K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral…ETHICON, Inc.20195
+2K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical20101

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201010
201110
201310
201420
201520
201810
201940
202020
202220
202420
202540
202620
FIG. 1 — Lineage of K050845, 1996–2026Source: 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 GAM? 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 GAM device

  1. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.7 · 15 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K960653Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)
Summary page 1
…Trade Name: MONOCRYL* Plus (Poliglecaprone 25) Antibacterial Suture Predicate Devices: MONOCRYL* (poliglecaprone 25) Suture (K960653 and K964072) VICRYL* Plus Antibacterial Suture (K032420) Statement of Intended Use: MO…
ETHICON, Inc.19962
*K964072Monocryl (Poliglecaprone 25) Suture, Undyed
Summary page 1
…me: MONOCRYL* Plus (Poliglecaprone 25) Antibacterial Suture Predicate Devices: MONOCRYL* (poliglecaprone 25) Suture (K960653 and K964072) VICRYL* Plus Antibacterial Suture (K032420) Statement of Intended Use: MONOCRYL* Plus…
ETHICON, Inc.19962
*K032420Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture
Summary page 1
…cterial Suture Predicate Devices: MONOCRYL* (poliglecaprone 25) Suture (K960653 and K964072) VICRYL* Plus Antibacterial Suture (K032420) Statement of Intended Use: MONOCRYL* Plus Antibacterial sutures are indicated for use in general soft…
ETHICON, Inc.20031

Also cleared against K960653: 7 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K061037PDS Plus Antibacterial SutureETHICON, Inc.200621
K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.20158
K201996Monocryl Plus Antibacterial SutureETHICON, Inc.20201

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 2, 2009Not classifiedZ-1312-2009Process controlSterility 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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K061037 (ETHICON, Inc., 2006) has gone furthest, with 21 descendants of its own.
  • 7 other devices also cite its predicate K960653.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

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

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

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

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, 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
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

What is it indicated for?

MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Indications for use as stated in the FDA summary.

Also cleared against K960653

7 other devices cite the same predicate.

  • K143584Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH · 2015
  • K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp. · 2013
  • K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 20101 recall
  • K072863Atramat PGC25 Poly (Glycolide-CO-Epsilon-Caprolactone) Surgical SuturesInternacional Farmaceutica, S.A. DE C.V. · 2008
  • K072229MonoswiftCp Medical · 20071 recall
  • K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007

More from ETHICON, Inc.

654 FDA decisions under this applicant name. See the company

  • P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc. · 2026
  • N12159/S129SURGICELTM POWDER Absorbable Hemostatic PowderETHICON, Inc. · 2026
  • P240035/S002ETHIZIA Hemostatic PatchETHICON, Inc. · 2026
  • P880047/S070GYNECARE INTERCEED™ Absorbable Adhesion BarrierETHICON, Inc. · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026

Recent decisions in GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K050845 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050845: Monocryl Plus Antibacterial Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050845

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