510(k) · Cleared
ClearedBiodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · FTM Mesh, Surgical
Cleared on May 26, 2016 as substantially equivalent to K992159 (Cook Biotech, Inc., 1999) and 2 other predicates after a 27-day review. Its family tree reaches back 5 generations to 1992. 6 later devices descend from it.
- Decided
- May 26, 2016
- Review
- 27 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K921895 (1992). 20 ancestors in all, the oldest K830889 (1983). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 1 generation backK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
- This deviceK161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal…Cook Biotech Incorporated · 2016
- Descendant · cites it directly · 4 of its ownK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019
- Descendant · 2 generations on · 3 of its ownK202430 Kerecis ReconstructKerecis Limited · 2021
- Descendant · 3 generations on · 0 of its ownK251844 Kerecis SurgiBind (50241)Kerecis Limited · 2025
- Descendant · 3 generations on · 0 of its ownK251224 Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243843 Tendon Protect (50242)Kerecis Limited · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated · 2019 · cites it directly4descendants
- K202430Kerecis ReconstructKerecis Limited · 2021 · 2 generations on3descendants
- K251844Kerecis SurgiBind (50241)Kerecis Limited · 2025 · 3 generations on0descendants
- K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025 · 3 generations on0descendants
- K243843Tendon Protect (50242)Kerecis Limited · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −1 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | — |
| 0 (this device) | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016 | — |
| +1 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… | Cook Biotech Incorporated | 2019 | — |
| +2 | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | — |
| +3 | K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 2025 | — |
| +3 | K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K992159 | Surgisis SlingSummary page 6…Surgisis Sling SIS Plastic Surgery SIS Fistula Plug Predicate Device (K992159) Matrix (K034039) (K050337) Intended to be used for… | 1999 |
| * | K034039 | Sis Plastic Surgery MatrixSummary page 6…gisis Sling SIS Plastic Surgery SIS Fistula Plug Predicate Device (K992159) Matrix (K034039) (K050337) Intended to be used for implantation… | 2004 |
| * | K050337 | Sis Fistula PlugSummary page 6…SIS Plastic Surgery SIS Fistula Plug Predicate Device (K992159) Matrix (K034039) (K050337) Intended to be used for implantation to reinforce soft… | 2005 |
What descends from it? (6)
2 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 24 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K191696 (Cook Biotech Incorporated, 2019) has gone furthest, with 4 descendants of its own.
- 12 other devices also cite its predicate K992159.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for…
Read the full statement (115 words)
For implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
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 where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161221: Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161221
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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