510(k) · Cleared
Recalled · Class II · 2012PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Jul 8, 2010 as substantially equivalent to K061037 (ETHICON, Inc., 2006) and 3 other predicates after a 140-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 8, 2010
- Review
- 140 days
- Class
- Class II
- Product code
- NEW
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K960653 (1996). 9 ancestors in all, the oldest K900198 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996 · Recalled
- 2 generations backK050845 Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005 · Recalled
- 1 generation backK061037 PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · Recalled
- This deviceK100461 PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010
- Descendant · cites it directly · 2 of its ownK130737 Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK142810 WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK130083 Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL)…Demetech Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK232372 Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024
- Descendant · 3 generations on · 0 of its ownK173779 Rexmono, PdrexSm Eng Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K130737Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014 · cites it directly2descendants
- K142810WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd. · 2014 · 2 generations on1descendant
- K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp. · 2013 · cites it directly1descendant
- K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024 · 2 generations on0descendants
- K173779Rexmono, PdrexSm Eng Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) | ETHICON, Inc. | 1996 | 2 |
| −2 | K050845 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2005 | 1 |
| −1 | K061037 | PDS Plus Antibacterial Suture | ETHICON, Inc. | 2006 | 9 |
| 0 (this device) | K100461 | PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut | Riverpoint Medical | 2010 | — |
| +1 | K130737 | Synthetic Absorbable Suture | Foosin Medical Supplies Inc., Ltd. | 2014 | — |
| +2 | K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Foosin Medical Supplies Inc., Ltd. | 2014 | — |
| +1 | K130083 | Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture | Demetech Corp. | 2013 | — |
| +2 | K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024 | — |
| +3 | K173779 | Rexmono, Pdrex | Sm Eng Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 NEW? 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 NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 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 |
|---|---|---|---|
| * | K061037 | PDS Plus Antibacterial SutureSummary page 2…All: Class if (special-controls); General. and Plastic Surgery Predicate Devices (applicable 5110(k) numbearlisted): 1. PDO:0w K061037 2. PGA: K972566 3. Fast Absorbing PGA: K023710 4. PGCL:… | 2006 |
| * | K972566 | Dexon VioletSummary page 2…. and Plastic Surgery Predicate Devices (applicable 5110(k) numbearlisted): 1. PDO:0w K061037 2. PGA: K972566 3. Fast Absorbing PGA: K023710 4. PGCL: K(960653~ Special Controls… | 1997 |
| * | K023710 | Visorb SwiftSummary page 2…le 5110(k) numbearlisted): 1. PDO:0w K061037 2. PGA: K972566 3. Fast Absorbing PGA: K023710 4. PGCL: K(960653~ Special Controls FDA Guidance "'Cla!~s II.Special Controls Guidance… | 2003 |
| * | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)Summary page 2…K061037 2. PGA: K972566 3. Fast Absorbing PGA: K023710 4. PGCL: K(960653~ Special Controls FDA Guidance "'Cla!~s II.Special Controls Guidance Document: Surgical Sutures; Guidance for I… | 1996 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2012 | Class II | Z-0347-2014 | Employee error | Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K130737 (Foosin Medical Supplies Inc., Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K061037.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, 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 | 2 | — | 0 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
PGA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. PGA suture is provided sterile as a single use device. Vilet Quick surgical suture is indicated for use in general soft tissue approximation, including use in ophthalmic procedures, where only short-term wound support is required. Vilet Quick is not intended for use in…
Read the full statement (180 words)
PGA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. PGA suture is provided sterile as a single use device.
Vilet Quick surgical suture is indicated for use in general soft tissue approximation, including use in ophthalmic procedures, where only short-term wound support is required. Vilet Quick is not intended for use in cardiovascular or neurological procedures. Vilet Quick suture is provided sterile as a single use device.
PGCL surgical suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures. PGCL suture is provided sterile as a single use device.
PDO surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and/or sclera). PDO Suture is not intended for use in adult cardiovascular tissue, microsurgery or neural tissue. PDO suture is provided sterile as a single use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100461
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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