510(k) · Cleared
ClearedAtramat and Sorb-Fast Polyglycolic Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Internacional Farmaceutica, S.A. DE C.V. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Apr 29, 2004 as substantially equivalent to K972566 (Davis & Geck, Inc., 1997) and 3 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Apr 29, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K900198 (1990). 6 ancestors in all. 1 later device descends from it, 1 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 deviceK040282 Atramat and Sorb-Fast Polyglycolic AcidInternacional Farmaceutica, S.A. DE C.V. · 2004
- Descendant · cites it directly · 0 of its ownK063462 Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063462Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd. · 2007 · cites it directly0descendants
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) | K040282 | Atramat and Sorb-Fast Polyglycolic Acid | Internacional Farmaceutica, S.A. DE C.V. | 2004 | — |
| +1 | K063462 | Neatstitch Neatclose Suturing Device | Neat Stitch, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972566 | Dexon VioletSummary page 2…following absorbable suture marketed by Davis & Geck: DEXON H® Polyglycolic Acid Synthetic Absorbable Surgical Sutures with Polycaprolactone Coating System. (K972566) and Ethicon Absorbable Poly (L- lactide/glycolide) Surgical Sutures with Poliglactina 370 and Calcium Stearate Coating… | 1997 |
| * | K964345 | Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, UndyedSummary page 2…actone Coating System. (K972566) and Ethicon Absorbable Poly (L- lactide/glycolide) Surgical Sutures with Poliglactina 370 and Calcium Stearate Coating System (K964345). With respect to substantial equivalence, the comparation device represents a virtually identical device. Materials,… | 1996 |
| * | K962480 | Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, UndyedSummary page 2…e requirements of USP 24. sorb-FAST® Polyglycolic Acid Absorption sutures are substantially equivalent to the following absorbable suture marketed by Ethicon (K962480 and K944110), Vicryl Rapide® is prepared with a mixture of copolymer of glycolide and L-lactide with Poliglactin 370 an… | 1996 |
| * | K944110 | Vicryl Rapide SutureSummary page 2…ts of USP 24. sorb-FAST® Polyglycolic Acid Absorption sutures are substantially equivalent to the following absorbable suture marketed by Ethicon (K962480 and K944110), Vicryl Rapide® is prepared with a mixture of copolymer of glycolide and L-lactide with Poliglactin 370 and Calcium St… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063462 | Neatstitch Neatclose Suturing Device | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K063462 (Neat Stitch, Ltd., 2007) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K972566.
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?
Atramat ® Polyglycolic Acid Sutures are 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.
sorb-FAST ® Polyglycolic Acid Sutures are indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required, but not for use in ligation, ophthalmic cardiovascular and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040282: Atramat and Sorb-Fast Polyglycolic Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040282
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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