510(k) · Cleared
Recalled · 2009Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed & Undyed, Braided and Monofilamt
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 15, 1995 after a 174-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled once.
- Decided
- Jun 15, 1995
- Review
- 174 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK946271 Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic…ETHICON, Inc. · 1995
- Descendant · cites it directly · 15 of its ownK991191 Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · Recalled
- Descendant · 2 generations on · 14 of its ownK992088 Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · 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 · 3 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · 3 generations on · 2 of its ownK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K991191Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · cites it directly15descendants
- K992088Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · 2 generations on14descendants
- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · 2 generations on10descendants
- K230311HyperSutureThreadstone, LLC · 2023 · 3 generations on4descendants
- K191268Force Fiber SutureTeleflex Medical Incorporated · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946271 | Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable… | ETHICON, Inc. | 1995 | — |
| +1 | K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | 1 |
| +2 | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | 6 |
| +2 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +3 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +3 | K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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 14.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 193 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 |
|---|---|---|---|---|
| Feb 2, 2009 | Not classified | Z-1309-2009 | Process control | Sterility 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?
- Of its descendants, K991191 (Genzyme Surgical Product (Genzyme Biosurgery), 1999) has gone furthest, with 15 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K946271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946271: Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed & Undyed, Braided and Monofilamt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946271
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026