510(k) · Cleared
ClearedBiodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · OXN Mesh, Surgical, Collagen, Fistula
Cleared on Dec 27, 2019 as substantially equivalent to K161221 (Cook Biotech Incorporated, 2016) and 5 other predicates after a 185-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it.
- Decided
- Dec 27, 2019
- Review
- 185 days
- Class
- Class II
- Product code
- OXN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K921895 (1992). 28 ancestors in all, the oldest K830889 (1983). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 2 generations backK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
- 1 generation backK161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal…Cook Biotech Incorporated · 2016
- This deviceK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019
- Descendant · cites it directly · 3 of its ownK202430 Kerecis ReconstructKerecis Limited · 2021
- Descendant · 2 generations on · 0 of its ownK251844 Kerecis SurgiBind (50241)Kerecis Limited · 2025
- Descendant · 2 generations on · 0 of its ownK251224 Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243843 Tendon Protect (50242)Kerecis Limited · 2025
Most influential descendants
Showing 4 of 4 · See all- K202430Kerecis ReconstructKerecis Limited · 2021 · cites it directly3descendants
- K251844Kerecis SurgiBind (50241)Kerecis Limited · 2025 · 2 generations on0descendants
- K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025 · 2 generations on0descendants
- K243843Tendon Protect (50242)Kerecis Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −2 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | — |
| −1 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016 | — |
| 0 (this device) | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… | Cook Biotech Incorporated | 2019 | — |
| +1 | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | — |
| +2 | K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 2025 | — |
| +2 | K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025 | — |
| +2 | K243843 | Tendon Protect (50242) | Kerecis Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 3 | 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 OXN? 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? (6)
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 |
|---|---|---|---|
| * | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugSummary page 7…2, 2019 510(k) Number: K191696 Device Classification: 21 CFR 878.3300 – Surgical Mesh Product Code: OXH, OXN, FTM Predicate Devices: K161221, K050337, K170016, K161221, K034039, K160896, K980431 This 510(k) is a bundled submission pertaining… | 2016 |
| * | K050337 | Sis Fistula PlugSummary page 7…510(k) Number: K191696 Device Classification: 21 CFR 878.3300 – Surgical Mesh Product Code: OXH, OXN, FTM Predicate Devices: K161221, K050337, K170016, K161221, K034039, K160896, K980431 This 510(k) is a bundled submission pertaining to four d… | 2005 |
| * | K170016 | Biodesign Fistula PlugSummary page 7…mber: K191696 Device Classification: 21 CFR 878.3300 – Surgical Mesh Product Code: OXH, OXN, FTM Predicate Devices: K161221, K050337, K170016, K161221, K034039, K160896, K980431 This 510(k) is a bundled submission pertaining to four devices ma… | 2017 |
| * | K034039 | Sis Plastic Surgery MatrixSummary page 7…191696 Device Classification: 21 CFR 878.3300 – Surgical Mesh Product Code: OXH, OXN, FTM Predicate Devices: K161221, K050337, K170016, K161221, K034039, K160896, K980431 This 510(k) is a bundled submission pertaining to four devices manufactured by Cook… | 2004 |
| * | K160896 | Ultrashape Power SystemSummary page 7…evice Classification: 21 CFR 878.3300 – Surgical Mesh Product Code: OXH, OXN, FTM Predicate Devices: K161221, K050337, K170016, K161221, K034039, K160896, K980431 This 510(k) is a bundled submission pertaining to four devices manufactured by Cook Biotech… | 2016 |
| * | K980431 | SurgisisSummary page 7…3300 – Surgical Mesh Product Code: OXH, OXN, FTM Predicate Devices: K161221, K050337, K170016, K161221, K034039, K160896, K980431 This 510(k) is a bundled submission pertaining to four devices manufactured by Cook Biotech Incorporated (CBI): 1. Biodesi… | 1998 |
| † | K132025 | Meso Bilayer Surgical Mesh | 2013 |
| † | K171817 | Biodesign Diaphragmatic Hernia Graft | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202430 | Kerecis Reconstruct | 2021 | 3 |
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 27 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K202430 (Kerecis Limited, 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K161221.
How does its category compare?
All OXN devicesOXN Mesh, Surgical, Collagen, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OXN
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · OXN
Too few OXN 510(k)s in any year since 2007 to give a median.
Recalls per year · OXN
No recall names OXN since 2007.
Adverse event reports per year · OXN
No MAUDE report names OXN since 2007.
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 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.
For implantation to reinforce soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191696: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191696
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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