510(k) · Cleared
ClearedMonoderm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corp · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on May 18, 2004 as substantially equivalent to K930772 (ETHICON, Inc., 1994) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1989. 29 later devices descend from it.
- Decided
- May 18, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K885018 (1989). 5 ancestors in all. 29 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK885018 Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc · 1989
- 1 generation backK013671 L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002
- This deviceK040477 MonodermSurgical Specialties Corp · 2004
- Descendant · cites it directly · 28 of its ownK052437 Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 2005
- Descendant · 2 generations on · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- Descendant · 3 generations on · 24 of its ownK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- Descendant · 3 generations on · 19 of its ownK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- Descendant · 3 generations on · 18 of its ownK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 2005 · cites it directly28descendants
- K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · 2 generations on26descendants
- K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · 3 generations on24descendants
- K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 3 generations on19descendants
- K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885018 | Absorbable Surgical Gut Suture* | United States Surgical, A Division of Tyco Healthc | 1989 | — |
| −1 | K013671 | L-25 Absorbable Surigcal Suture | United States Surgical, A Division of Tyco Healthc | 2002 | — |
| 0 (this device) | K040477 | Monoderm | Surgical Specialties Corp | 2004 | — |
| +1 | K052437 | Modified Monoderm Monofilament, Synthetic, Absorbable Suture | Surgical Specialties Corp | 2005 | — |
| +2 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| +3 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| +3 | K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | 1 |
| +3 | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K930772 | Ethicon* Monocryl (Poliglecaprone 25) SutureSummary page 1…ophthalmic surgery. Predicate Devices Ethicon's Monocryl(Poliglecaprone 25) E caprolactone/Glycolide 510 (k) K930772 U.S. Surgical's Caprosyn (Polyglytone 6211) Glycolide, caprolactone.… | 1994 |
| * | K013671 | L-25 Absorbable Surigcal SutureSummary page 1…Caprosyn (Polyglytone 6211) Glycolide, caprolactone. trimethylene carbonate and lactide. 510 (k) K013671 Device Description: Coated MonodermXM(Polyglactone 72) suture is a monofilament… | 2002 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052437 | Modified Monoderm Monofilament, Synthetic, Absorbable Suture | 2005 | 28 |
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 15 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K052437 (Surgical Specialties Corp, 2005) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K930772.
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?
Monoderm sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040477: Monoderm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040477
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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