510(k) · Cleared
ClearedQuill Monoderm Knotless Tissue-Closure Device, Variable Loop Design
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corporation · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jul 30, 2014 as substantially equivalent to K122898 (Surgical Specialties Corp. Dba Angiotech, 2012) and 2 other predicates after a 28-day review. Its family tree reaches back 11 generations to 2002. 10 later devices descend from it.
- Decided
- Jul 30, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K014153 (2002). 33 ancestors in all, the oldest K885018 (1989). 10 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 7 generations between
- 3 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 2 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- This deviceK141778 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014
- Descendant · cites it directly · 8 of its ownK151200 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX…ETHICON, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 7 of its ownK182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices…ETHICON, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 2 of its ownK221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK232246 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone)…M/s. Meril Endo Surgery Private Limited. · 2024
- Descendant · 3 generations on · 1 of its ownK192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. · 2020 · Recalled
Show all 11 generations
- Root · 11 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 10 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 9 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 8 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 7 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 6 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 5 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- 4 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 3 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 2 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- This deviceK141778 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc. · 2015 · cites it directly8descendants
- K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc. · 2019 · 2 generations on7descendants
- K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022 · 3 generations on2descendants
- K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited. · 2024 · 2 generations on1descendant
- K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −10 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −9 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −8 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −7 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −6 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −5 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| −4 | 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 |
| −2 | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| −1 | K123836 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| 0 (this device) | K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corporation | 2014 | — |
| +1 | K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral… | ETHICON, Inc. | 2015 | 1 |
| +2 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral… | ETHICON, Inc. | 2019 | 5 |
| +3 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2022 | — |
| +2 | K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless… | M/s. Meril Endo Surgery Private Limited. | 2024 | — |
| +3 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2020 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 1…Product code, GAM 21 CER 878.4493 Class 11 Legally marketed device K122898: QuiITM MonodermTM Knotless Tissue-Closure to which the device is Device, Variab… | 2012 |
| * | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 1…to which the device is Device, Variable Loop Design, Size -0- substantially equivalent: K 123409: QuiITM MonoderMmM Knotless Tissue-Closure Device, Variabl… | 2012 |
| * | K123836 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 1…MmM Knotless Tissue-Closure Device, Variable Loop Design, Size 2-0 K123836: QuiITIM MonodermuTM Knotless Tissue-Closure Device, Vari… | 2012 |
What descends from it? (10)
2 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 12 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 12 of the 33 ancestors have a recall of any class.
- Of its descendants, K151200 (ETHICON, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K122898.
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. 2014, 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?
Quill™ MONODERM™ Knotless Tissue-Closure Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141778: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141778
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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