510(k) · Cleared
Recalled · Class II · 2025VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jun 27, 2019 as substantially equivalent to K946271 (ETHICON, Inc., 1995) and 1 other predicate after a 220-day review. Its family tree reaches back 3 generations to 1996. It has been recalled 3 times.
- Decided
- Jun 27, 2019
- Review
- 220 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K960653 (1996). 6 ancestors in all, the oldest K946271 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996 · Recalled
- 2 generations backK050845 Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005 · Recalled
- 1 generation backK061037 PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · Recalled
- This deviceK183183 VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture…ETHICON, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) | ETHICON, Inc. | 1996 | 2 |
| −2 | K050845 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2005 | 1 |
| −1 | K061037 | PDS Plus Antibacterial Suture | ETHICON, Inc. | 2006 | 9 |
| 0 (this device) | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II… | ETHICON, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 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 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 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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 |
|---|---|---|---|
| * | K946271 | Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed…Summary page 5…ces: Device Company Product Code 510(k)/ NDA Number VICRYL™ (Polyglactin 910) Ethicon, Inc. GAM K946271 Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed & Undyed, Braided and Monofilament PDS™ II (Polydioxanone) Sut… | 1995 |
| Kept off the family tree | N18331 | PDS™ II (Polydioxanone) Suture Dyed & Undyed Number could not be read Summary page 5…ided Coated and Uncoated Synthetic Absorbable Suture, Dyed & Undyed, Braided and Monofilament PDS™ II (Polydioxanone) Suture Ethicon, Inc. NEW N18331 Dyed & Undyed PDS™ Plus Antibacterial Suture Ethicon, Inc. NEW K061037 Device Description: VICRYL™ (Po… | |
| * | K061037 | PDS Plus Antibacterial SutureSummary page 5…t PDS™ II (Polydioxanone) Suture Ethicon, Inc. NEW N18331 Dyed & Undyed PDS™ Plus Antibacterial Suture Ethicon, Inc. NEW K061037 Device Description: VICRYL™ (Polyglactin 910) Suture is a sterile, synthetic, absorbable, surgical suture composed of a copolym… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2025 | Class II | Z-1513-2025 | Process control | Identified curing issues with the silicone during the needles manufacturing process. |
| Sep 25, 2024 | Class II | Z-0319-2025 | Under Investigation by firm | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package. |
| May 10, 2024 | Class II | Z-2146-2024 | 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 . |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 9.3 years on median.
- 6 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K946271.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
VICRYLTM Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDSTM II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These…
Read the full statement (156 words)
VICRYLTM Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.
PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDSTM II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.
PDSTM Plus Suture is 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). PDSTM Plus Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183183: VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile 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/K183183
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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