510(k) · Cleared
ClearedModified Monoderm Monofilament, Synthetic, Absorbable Suture
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 Nov 7, 2005 as substantially equivalent to K930772 (ETHICON, Inc., 1994) and 1 other predicate after a 62-day review. Its family tree reaches back 3 generations to 1989. 28 later devices descend from it.
- Decided
- Nov 7, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K885018 (1989). 6 ancestors in all. 28 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK885018 Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc · 1989
- 2 generations backK013671 L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002
- 1 generation backK040477 MonodermSurgical Specialties Corp · 2004
- This deviceK052437 Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp · 2005
- Descendant · cites it directly · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- Descendant · 2 generations on · 24 of its ownK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- Descendant · 2 generations on · 19 of its ownK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- Descendant · 2 generations on · 18 of its ownK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- Descendant · 3 generations on · 11 of its ownK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · cites it directly26descendants
- K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · 2 generations on24descendants
- K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 2 generations on19descendants
- K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 2 generations on18descendants
- K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885018 | Absorbable Surgical Gut Suture* | United States Surgical, A Division of Tyco Healthc | 1989 | — |
| −2 | K013671 | L-25 Absorbable Surigcal Suture | United States Surgical, A Division of Tyco Healthc | 2002 | — |
| −1 | K040477 | Monoderm | Surgical Specialties Corp | 2004 | — |
| 0 (this device) | K052437 | Modified Monoderm Monofilament, Synthetic, Absorbable Suture | Surgical Specialties Corp | 2005 | — |
| +1 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| +2 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| +2 | K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | 1 |
| +2 | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| +3 | K123836 | 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 |
|---|---|---|
| 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 14.7 · 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? (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 Surgical Specialties Corporation's (Polyglvtone 72) Glycolide, and e-… | 1994 |
| * | K040477 | MonodermSummary page 1…Surgical Specialties Corporation's (Polyglvtone 72) Glycolide, and e- caprolactone. 510 (k) K040477 Device Description: MonodermTM suture is a monofilamen: synthetic absorbable surgical… | 2004 |
What descends from it? (28)
See all 283 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)
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 16 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K072028 (Surgical Specialties Corp, 2007) has gone furthest, with 26 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?
MonodermTM 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/K052437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052437: Modified Monoderm Monofilament, Synthetic, Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052437
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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