510(k) · Cleared
Recalled · Class II · 2014Bondek Plus 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 Sep 3, 1999 as substantially equivalent to K905482 (Pfizer Hospital Products Group, Inc., 1991) and 5 other predicates after a 74-day review. Its family tree reaches back 2 generations to 1990. 14 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 3, 1999
- Review
- 74 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 6
- Predicates
- 7
Its longest line of descent runs back 2 generations to K900198 (1990). 8 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK900198 Dexon II Absorbable Surgical Suture, U.S.P.American Cyanamid Co. · 1990
- 1 generation backK972566 Dexon VioletDavis & Geck, Inc. · 1997
- This deviceK992088 Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999
- 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
- Descendant · 3 generations on · 1 of its ownK210675 EasyWhipWinter Innovations, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900198 | Dexon II Absorbable Surgical Suture, U.S.P. | American Cyanamid Co. | 1990 | — |
| −1 | K972566 | Dexon Violet | Davis & Geck, Inc. | 1997 | — |
| 0 (this device) | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | — |
| +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 | — |
| +3 | K210675 | EasyWhip | Winter Innovations, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp… | 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…Absorbable Surgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens®… | 1993 |
| * | K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture Cleared while this submission was under review Summary page 2…urgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens® PGA suture (#… | 1999 |
| * | K972566 | Dexon VioletSummary page 2…and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens® PGA suture (#K965162). The determination of substantial equivalence for t… | 1997 |
| * | K951352 | Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid SutureSummary page 2…rmance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens® PGA suture (#K965162). The determination of substantial equivalence for this device… | 1995 |
| * | K900198 | Dexon II Absorbable Surgical Suture, U.S.P.Summary page 2…racteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens® PGA suture (#K965162). The determination of substantial equivalence for this device was based… | 1990 |
| * | K965162 | Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated…Summary page 2…Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens® PGA suture (#K965162). The determination of substantial equivalence for this device was based on a detailed device description, performance testing a… | 1997 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force… | 2018 | 10 |
| K180625 | Rondek PGA Suture (Beige or Violet) | 2018 | 0 |
| K120284 | Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with… | 2012 | 0 |
| K060801 | Dekna-Lok Model BP1000V2L | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2014 | Class II | Z-1535-2014 | Other | The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. |
| Jun 6, 2007 | Not classified | Z-1019-2007 | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
| Jun 6, 2007 | Not classified | Z-1011-2007 | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
| Jun 6, 2007 | Not classified | Z-1012-2007 | Other | The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
| Jun 6, 2007 | Not classified | Z-1013-2007 | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
| Jun 6, 2007 | Not classified | Z-1014-2007 | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K181774 (Teleflex Medical Incorporated, 2018) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K905482.
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® Plus 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/K992088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992088: Bondek Plus 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/K992088
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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