510(k) · Cleared
ClearedRestorelle Polypropylene Y Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on May 17, 2012 as substantially equivalent to K101722 (C.R. Bard, Inc., 2011) and 1 other predicate after a 279-day review. Its family tree reaches back 11 generations to 1993. 6 later devices descend from it.
- Decided
- May 17, 2012
- Review
- 279 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K931386 (1993). 36 ancestors in all, the oldest K905655 (1990). 6 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations between
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 1 generation backK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
- This deviceK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
- Descendant · cites it directly · 2 of its ownK123914 Restorelle Y ContourColoplast A/S · 2013
- Descendant · 2 generations on · 1 of its ownK140116 Restorelle Y Contour MeshColoplast A/S · 2014
- Descendant · cites it directly · 1 of its ownK123028 Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK173501 Meridian Vaginal Positioning System (VPS)Coloplast · 2018
- Descendant · 2 generations on · 0 of its ownK150023 Vertessa Lite Y-MeshCaldera Medical, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 6 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 5 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 4 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 1 generation backK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
- This deviceK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123914Restorelle Y ContourColoplast A/S · 2013 · cites it directly2descendants
- K140116Restorelle Y Contour MeshColoplast A/S · 2014 · 2 generations on1descendant
- K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013 · cites it directly1descendant
- K173501Meridian Vaginal Positioning System (VPS)Coloplast · 2018 · 3 generations on0descendants
- K150023Vertessa Lite Y-MeshCaldera Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −10 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −9 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −8 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −7 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −6 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −5 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −4 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −3 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −2 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| −1 | K092207 | Restorelle Polypropylene Mesh | Mpathy Medical Devices, Inc. | 2009 | — |
| 0 (this device) | K112322 | Restorelle Polypropylene Y Mesh | Coloplast A/S | 2012 | — |
| +1 | K123914 | Restorelle Y Contour | Coloplast A/S | 2013 | — |
| +2 | K140116 | Restorelle Y Contour Mesh | Coloplast A/S | 2014 | — |
| +1 | K123028 | Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2013 | — |
| +3 | K173501 | Meridian Vaginal Positioning System (VPS) | Coloplast | 2018 | — |
| +2 | K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2015 | — |
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 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K101722 | Alyte Y-Mesh GraftSummary page 1…OTO-Mesh, Surgical, Gynecological, For Apical Vaginal Prolapse, Transabdominally Placed. Predicate Devices: ALYTETM Y-Mesh Graft (Bard Medical K101722) Restorelle Y Mesh (Mpathy Medical K092207) Purpose of Submission: The purpose of this submission is to obtai… | 2011 |
| * | K092207 | Restorelle Polypropylene MeshSummary page 1…Prolapse, Transabdominally Placed. Predicate Devices: ALYTETM Y-Mesh Graft (Bard Medical K101722) Restorelle Y Mesh (Mpathy Medical K092207) Purpose of Submission: The purpose of this submission is to obtain a specific indication for use statement for sacrocolpopexy f… | 2009 |
What descends from it? (6)
3 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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 36 ancestors have a recall of any class.
- Of its descendants, K123914 (Coloplast A/S, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K101722.
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. 2012, 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?
Restorelle Y is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112322: Restorelle Polypropylene Y Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112322
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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