510(k) Report

510(k) · Cleared

Cleared

Artisyn Y-Shaped Mesh

K113205510(k) TraditionalCleared Jun 11, 2012224-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

ETHICON, Inc. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Cleared on Jun 11, 2012 as substantially equivalent to K101722 (C.R. Bard, Inc., 2011) and 2 other predicates after a 224-day review. Its family tree reaches back 11 generations to 1993.

Decided
Jun 11, 2012
Review
224 days
Class
Class II
Product code
OTO
Recalls
None
Predicates
3

Its longest line of descent runs back 11 generations to K931386 (1993). 37 ancestors in all, the oldest K905655 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2009: 2 other ancestors2006: 2 other ancestors2004: 3 other ancestors2002: 5 other ancestors2000: 1 other ancestor1990: 1 other ancestor2003: 1 other ancestor2001: 4 other ancestors1998: 2 other ancestors1996: 2 other ancestors1994: 1 other ancestor1992: 1 other ancestorK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK972651 · IN-Sling · Influence, Inc. · 1997K980482 · Triangle Sling · Influence, Inc. · 1998K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K010931 · Ams Sacral Colpopexy Sling, Model 72403501 · American Medical Systems, Inc. · 2001×3: 3 generations cleared close together, K033636 (2003), K040521 (2004), K040623 (2004) K071512 · Gynecare Prolift +M* Pelvic Floor Repair Systems · ETHICON, Inc. · 2008K082216 · TBD Ethicon Mesh · ETHICON, Inc. · 200819901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors4 generations back: 12 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor K082216 · TBD Ethicon Mesh · ETHICON, Inc. · 2008K071512 · Gynecare Prolift +M* Pelvic Floor Repair Systems · ETHICON, Inc. · 2008K040623 · Ams Perigee System · American Medical Systems, Inc. · 2004K040521 · Modification to Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2004K033636 · Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2003K010931 · Ams Sacral Colpopexy Sling, Model 72403501 · American Medical Systems, Inc. · 2001K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K980482 · Triangle Sling · Influence, Inc. · 1998K972651 · IN-Sling · Influence, Inc. · 1997K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993−10−50
  1. Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 7 generations between
  3. 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  4. 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
  5. 1 generation backK082216 TBD Ethicon MeshETHICON, Inc. · 2008
  6. This deviceK113205 Artisyn Y-Shaped MeshETHICON, Inc. · 2012
Show all 11 generations
  1. Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. 6 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
  7. 5 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  8. 4 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  9. 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  10. 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
  11. 1 generation backK082216 TBD Ethicon MeshETHICON, Inc. · 2008
  12. This deviceK113205 Artisyn Y-Shaped MeshETHICON, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−10K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−9K972651IN-SlingInfluence, Inc.1997—
−8K980482Triangle SlingInfluence, Inc.1998—
−7K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
−6K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.2001—
−5K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
−4K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
−3K040623Ams Perigee SystemAmerican Medical Systems, Inc.2004—
−2K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.2008—
−1K082216TBD Ethicon MeshETHICON, Inc.2008—
0 (this device)K113205Artisyn Y-Shaped MeshETHICON, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199410
199620
199820
200010
200140
200250
200310
200430
200620
200920
201110
FIG. 1 — Lineage of K113205, 1993–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K101722Alyte Y-Mesh Graft
Summary page 1
…1 CFR878.3300 | OTO - Mesh, Surgical, Gynecologic, For Apical Vaginal Prolapse, Transabdominally Placed. FTL — Mesh, Surgical, Polymeric ALYTE™ Y-Mesh Graft, CR BARD, K101722 GYNECARE GYNEMESH M® Partially Absorbable Mesh , ETHICON Inc., K082216 RESTORELLE® Y, Mpathy Medical Devices, Ltd., K092207 ARTI…
C.R. Bard, Inc.2011—
*K082216TBD Ethicon Mesh
Summary page 1
…Prolapse, Transabdominally Placed. FTL — Mesh, Surgical, Polymeric ALYTE™ Y-Mesh Graft, CR BARD, K101722 GYNECARE GYNEMESH M® Partially Absorbable Mesh , ETHICON Inc., K082216 RESTORELLE® Y, Mpathy Medical Devices, Ltd., K092207 ARTISYN™ Y-Shaped Mesh consists of two pieces of partially absorbable mesh…
ETHICON, Inc.2008—
*K092207Restorelle Polypropylene Mesh
Summary page 1
…cal, Polymeric ALYTE™ Y-Mesh Graft, CR BARD, K101722 GYNECARE GYNEMESH M® Partially Absorbable Mesh , ETHICON Inc., K082216 RESTORELLE® Y, Mpathy Medical Devices, Ltd., K092207 ARTISYN™ Y-Shaped Mesh consists of two pieces of partially absorbable mesh provided in a Y shape: a vaginal section with anterio…
Mpathy Medical Devices, Inc.2009—

Also cleared against K101722: 2 other devices →

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 19 years and passes through 5 companies; a new generation was cleared every 10 months on median.
  • 5 of the 37 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K101722.

How does its category compare?

All OTO devices

OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OTO

1in 2017

2009: 12011: 12012: 72013: 42014: 12015: 22017: 1
2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTO

95in 2013

2012: 101 days median2013: 95 days median
2007high 101 (2012) · low 95 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OTO

No recall names OTO since 2007.

Adverse event reports per year · OTO

79in 2025

2011: 72012: 1602013: 2,2722014: 2672015: 4482016: 1562017: 752018: 1452019: 3472020: 1532021: 2922022: 1122023: 1012024: 1132025: 79
2007high 2,272 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20111—07
201271010160
201349502,272
20141—0267
20152—0448
20160—0156
20171—075
20180—0145
20190—0347
20200—0153
20210—0292
20220—0112
20230—0101
20240—0113
20250—079
20260—0—

What is it indicated for?

ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparatomy or laparéscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K101722

2 other devices cite the same predicate.

  • K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013
  • K112322Restorelle Polypropylene Y MeshColoplast A/S · 2012

More from ETHICON, Inc.

654 FDA decisions under this applicant name. See the company

  • P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc. · 2026
  • N12159/S129SURGICELTM POWDER Absorbable Hemostatic PowderETHICON, Inc. · 2026
  • P240035/S002ETHIZIA Hemostatic PatchETHICON, Inc. · 2026
  • P880047/S070GYNECARE INTERCEED™ Absorbable Adhesion BarrierETHICON, Inc. · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026

Recent decisions in OTO

The OTO category page

  • K171271Polyform Synthetic MeshBoston Scientific Corporation · 2017
  • K150023Vertessa Lite Y-MeshCaldera Medical, Inc. · 2015
  • K150016Vertessa LiteCaldera Medical, Inc. · 2015
  • K140116Restorelle Y Contour MeshColoplast A/S · 2014
  • K132061Restorelle M, Restorelle XLColoplast Corp. · 2013

https://510kreport.com/device/K113205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113205: Artisyn Y-Shaped Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113205

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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