510(k) · Cleared
ClearedAvaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Jan 15, 2009 as substantially equivalent to K063712 (C.R. Bard, Inc., 2007) and 1 other predicate after a 23-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Jan 15, 2009
- Review
- 23 days
- Class
- Class III
- Product code
- OTP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K991400 (1999). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 4 generations backK033376 Ugytex MeshSofradim Production · 2004
- 3 generations backK051503 Ugytex Sual Knit MeshSofradim Production · 2005
- 2 generations backK063712 Avaulta Support System/Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc. · 2007
- 1 generation backK082571 Avaulta Support SystemC.R. Bard, Inc. · 2008
- This deviceK083839 Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic…C.R. Bard, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −4 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −3 | K051503 | Ugytex Sual Knit Mesh | Sofradim Production | 2005 | — |
| −2 | K063712 | Avaulta Support System/Avaulta Plus Biosynthetic Support System | C.R. Bard, Inc. | 2007 | — |
| −1 | K082571 | Avaulta Support System | C.R. Bard, Inc. | 2008 | — |
| 0 (this device) | K083839 | Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System | C.R. Bard, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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 OTP? 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 |
|---|---|---|---|
| * | K063712 | Avaulta Support System/Avaulta Plus Biosynthetic Support SystemSummary page 1…R 878.3300 Classification Panel: General and Plastic Surgery PREDICATE DEVICE NAME: Trade Names: Avaulta Solo™ Support System Avaulta Plus™ Biosynthetic Support System K063712 and K082571 DEVICE DESCRIPTION: The Avaulta™ Support System includes a sterile, single use, permanent implant that provides lo… | 2007 |
| * | K082571 | Avaulta Support SystemSummary page 1…lassification Panel: General and Plastic Surgery PREDICATE DEVICE NAME: Trade Names: Avaulta Solo™ Support System Avaulta Plus™ Biosynthetic Support System K063712 and K082571 DEVICE DESCRIPTION: The Avaulta™ Support System includes a sterile, single use, permanent implant that provides long term rein… | 2008 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K063712.
How does its category compare?
All OTP devicesOTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OTP
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OTP
71in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTP
No recall names OTP since 2007.
Adverse event reports per year · OTP
26in 2025
MAUDE reports naming product code OTP, 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 | 4 | 90 | 0 | 1 |
| 2008 | 8 | 103 | 0 | 0 |
| 2009 | 6 | 21 | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 5 | 71 | 0 | 32 |
| 2012 | 2 | — | 0 | 494 |
| 2013 | 0 | — | 0 | 7,150 |
| 2014 | 0 | — | 0 | 778 |
| 2015 | 0 | — | 0 | 684 |
| 2016 | 0 | — | 0 | 415 |
| 2017 | 0 | — | 0 | 273 |
| 2018 | 0 | — | 0 | 392 |
| 2019 | 0 | — | 0 | 368 |
| 2020 | 0 | — | 0 | 175 |
| 2021 | 0 | — | 0 | 647 |
| 2022 | 0 | — | 0 | 114 |
| 2023 | 0 | — | 0 | 59 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Avaulta™ Support System 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/K083839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083839: Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083839
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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