510(k) · Cleared
ClearedBiodesign Surgisis Anterior Posterior Pelvic Floor Grafts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Apr 5, 2013 as substantially equivalent to K992159 (Cook Biotech, Inc., 1999) and 1 other predicate after a 93-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Apr 5, 2013
- Review
- 93 days
- Class
- Class III
- Product code
- PAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K921895 (1992). 11 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- This deviceK130006 Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| 0 (this device) | K130006 | Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts | Cook Biotech Incorporated | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 PAI? 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 |
|---|---|---|---|
| * | K992159 | Surgisis SlingSummary page 4…ior Pelvic Floor Grafts Manufacturer Cook Biotech Cook Biotech Cook Biotech 510 (k) K 130006 K992159 K(062696 Number Intended Use Cook"' Biodesign For implantation to Surgisis is intende… | 1999 |
| * | K062696 | Surgisis, Surgisis ESSummary page 4…r Grafts Manufacturer Cook Biotech Cook Biotech Cook Biotech 510 (k) K 130006 K992159 K(062696 Number Intended Use Cook"' Biodesign For implantation to Surgisis is intended for SUrgisis… | 2006 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
- 12 other devices also cite its predicate K992159.
How does its category compare?
All PAI devicesPAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PAI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PAI
Too few PAI 510(k)s in any year since 2007 to give a median.
Recalls per year · PAI
No recall names PAI since 2007.
Adverse event reports per year · PAI
1in 2022
MAUDE reports naming product code PAI, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cook® Biodesign® Surgisis® Anterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of anterior and anterior/apical vaginal vault prolapse.
Cook® Biodesign® Surgisis® Posterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior and posterior/apical vaginal vault prolapse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130006: Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130006
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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