510(k) · Cleared
ClearedMONOFIX PGCL, knotless wound closure device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samyang Holdings Corp., Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Aug 5, 2022 as substantially equivalent to K141778 (Surgical Specialties Corporation, 2014) after a 336-day review. Its family tree reaches back 12 generations to 2002.
- Decided
- Aug 5, 2022
- Review
- 336 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K014153 (2002). 34 ancestors in all, the oldest K885018 (1989). No later device cites it as a predicate yet.
- Root · 12 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 8 generations between
- 3 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 2 generations backK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK141778 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014
- This deviceK212810 MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd. · 2022
Show all 12 generations
- Root · 12 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 11 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 10 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 9 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 8 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 7 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 6 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- 5 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 4 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 3 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 2 generations backK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK141778 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014
- This deviceK212810 MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −11 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −10 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −9 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −8 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −7 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −6 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| −5 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| −4 | 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 | — |
| −2 | K123836 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| −1 | K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corporation | 2014 | — |
| 0 (this device) | K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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? (1)
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 |
|---|---|---|---|
| * | K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 4…closure in controlled clinical or preclinical studies for minimally invasive or open surgery. 06. Predicate devices Predicate device 510(k) Number: K141778 Device Name: Quill™ Monoderm™ Knotless Tissue-Closure(PGA-PCL), Variable Loop Design Manufacturer: Surgical Special… | 2014 |
| † | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 12 of the 34 ancestors have a recall of any class.
- 1 other device also cites its predicate K141778.
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. 2022, this device’s year, is highlighted.
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?
MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212810 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212810: MONOFIX PGCL, knotless wound closure device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212810
Report an extraction error
Are you the manufacturer?
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