510(k) · Cleared
ClearedBard Sacrocolpopexy Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Nov 10, 2009 as substantially equivalent to K053361 (Mpathy Medical Devices, Ltd., 2006) and 2 other predicates after a 235-day review. Its family tree reaches back 8 generations to 1993. 9 later devices descend from it.
- Decided
- Nov 10, 2009
- Review
- 235 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K931386 (1993). 21 ancestors in all, the oldest K905655 (1990). 9 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 6 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 5 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 4 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 3 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 2 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 1 generation backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- This deviceK090739 Bard Sacrocolpopexy GraftC.R. Bard, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK101722 Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
- Descendant · 3 generations on · 2 of its ownK123914 Restorelle Y ContourColoplast A/S · 2013
- Descendant · 4 generations on · 1 of its ownK140116 Restorelle Y Contour MeshColoplast A/S · 2014
- Descendant · 2 generations on · 1 of its ownK123028 Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K101722Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011 · cites it directly8descendants
- K112322Restorelle Polypropylene Y MeshColoplast A/S · 2012 · 2 generations on6descendants
- K123914Restorelle Y ContourColoplast A/S · 2013 · 3 generations on2descendants
- K140116Restorelle Y Contour MeshColoplast A/S · 2014 · 4 generations on1descendant
- K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −7 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −6 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −5 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −4 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −3 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −2 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −1 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K090739 | Bard Sacrocolpopexy Graft | C.R. Bard, Inc. | 2009 | — |
| +1 | K101722 | Alyte Y-Mesh Graft | C.R. Bard, Inc. | 2011 | — |
| +2 | K112322 | Restorelle Polypropylene Y Mesh | Coloplast A/S | 2012 | — |
| +3 | K123914 | Restorelle Y Contour | Coloplast A/S | 2013 | — |
| +4 | K140116 | Restorelle Y Contour Mesh | Coloplast A/S | 2014 | — |
| +2 | K123028 | Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 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
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 |
|---|---|---|---|
| * | K053361 | Modification to: Minimesh Polypropylene MeshSummary page 1…ce: 21 €FR 878.3300 Classification Panel: General and Plastic Surgery C. PREDICATE DEVICE NAME: Trade Names: Mpathy Medical Devices Ltd. Minimesh® Polypropylene Mesh - K053361 and ) American Medical Systems Y-Mesh Graft — K033636, K040521 D. DEVICE DESCRIPTION: The Alyte™ Y-Mesh Graft is a surgical imp… | 2006 |
| * | K033636 | Ams Large Pore Polypropylene MeshSummary page 1…Plastic Surgery C. PREDICATE DEVICE NAME: Trade Names: Mpathy Medical Devices Ltd. Minimesh® Polypropylene Mesh - K053361 and ) American Medical Systems Y-Mesh Graft — K033636, K040521 D. DEVICE DESCRIPTION: The Alyte™ Y-Mesh Graft is a surgical implant used in the repair of vaginal wall prolapse. The… | 2003 |
| * | K040521 | Modification to Ams Large Pore Polypropylene MeshSummary page 1…urgery C. PREDICATE DEVICE NAME: Trade Names: Mpathy Medical Devices Ltd. Minimesh® Polypropylene Mesh - K053361 and ) American Medical Systems Y-Mesh Graft — K033636, K040521 D. DEVICE DESCRIPTION: The Alyte™ Y-Mesh Graft is a surgical implant used in the repair of vaginal wall prolapse. The graft is… | 2004 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101722 | Alyte Y-Mesh Graft | 2011 | 8 |
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 5 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K101722 (C.R. Bard, Inc., 2011) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K053361.
How does its category compare?
All OTO devicesOTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OTO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OTO
95in 2013
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
MAUDE reports naming product code OTO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 7 | 101 | 0 | 160 |
| 2013 | 4 | 95 | 0 | 2,272 |
| 2014 | 1 | — | 0 | 267 |
| 2015 | 2 | — | 0 | 448 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 0 | — | 0 | 145 |
| 2019 | 0 | — | 0 | 347 |
| 2020 | 0 | — | 0 | 153 |
| 2021 | 0 | — | 0 | 292 |
| 2022 | 0 | — | 0 | 112 |
| 2023 | 0 | — | 0 | 101 |
| 2024 | 0 | — | 0 | 113 |
| 2025 | 0 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alyte™ Y-Mesh Graft is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090739: Bard Sacrocolpopexy Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090739
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