510(k) · Cleared
Recalled · 2010Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Surgical Product (Genzyme Biosurgery) · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jun 22, 1999 as substantially equivalent to K905482 (Pfizer Hospital Products Group, Inc., 1991) and 3 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1991. 15 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K905482 (1991). 4 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK905482 Bondek Polyglycolic Acid Synthetic Absorb. SuturePfizer Hospital Products Group, Inc. · 1991 · Recalled
- This deviceK991191 Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999
- Descendant · cites it directly · 14 of its ownK992088 Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · Recalled
- Descendant · cites it directly · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- Descendant · 2 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · 2 generations on · 2 of its ownK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
- Descendant · 3 generations on · 1 of its ownK242201 HyperSuture White/Green Extension LineThreadstone, LLC · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K992088Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · cites it directly14descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905482 | Bondek Polyglycolic Acid Synthetic Absorb. Suture | Pfizer Hospital Products Group, Inc. | 1991 | 1 |
| 0 (this device) | K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | — |
| +1 | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | 6 |
| +1 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +2 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +2 | K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019 | — |
| +3 | K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K905482 | Bondek Polyglycolic Acid Synthetic Absorb. SutureSummary page 2…Synthetic Absorbable Surgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#¥K905482 and #K930378), Ethicon, Inc V1cry1 suture (#K946271, #K915835), and Lukens Medical Corp. Lukens® PGA suture (#K965 162). _ The d… | 1991 |
| Kept off the family tree | K930378 | FDA’s K930378 is 25 CM2, 75 CM2, 150 CM2 Flask, Catalog #03-441 Our OCR of the scanned summary read K930378, FDA’s number for 25 CM2, 75 CM2, 150 CM2 Flask, Catalog #03-441 (Proteins Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bondek Synthetic Absorbable Surgical Suture”. Kept off the family tree. Summary page 2…orbable Surgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#¥K905482 and #K930378), Ethicon, Inc V1cry1 suture (#K946271, #K915835), and Lukens Medical Corp. Lukens® PGA suture (#K965 162). _ The determination… | 1993 |
| * | K946271 | Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed…Summary page 2…ntended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#¥K905482 and #K930378), Ethicon, Inc V1cry1 suture (#K946271, #K915835), and Lukens Medical Corp. Lukens® PGA suture (#K965 162). _ The determination of substantial equivalence for this dev… | 1995 |
| * | K915835 | Coated Vicryl* IISummary page 2…e, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#¥K905482 and #K930378), Ethicon, Inc V1cry1 suture (#K946271, #K915835), and Lukens Medical Corp. Lukens® PGA suture (#K965 162). _ The determination of substantial equivalence for this device was ba… | 1992 |
| * | K965162 | Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated…Summary page 2…the Bondek Synthetic Absorbable Surgical Suture (#¥K905482 and #K930378), Ethicon, Inc V1cry1 suture (#K946271, #K915835), and Lukens Medical Corp. Lukens® PGA suture (#K965 162). _ The determination of substantial equivalence for this device was based on a ~ detailed device description, performance test… | 1997 |
What descends from it? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture | 1999 | 14 |
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force… | 2018 | 10 |
| K120284 | Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with… | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2010 | Not classified | Z-2287-2010 | Labeling mix-ups | Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
Bondek® Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991191: Bondek Polyglycolic Acid 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/K991191
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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