510(k) · Cleared
ClearedFortaflex Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organogenesis, Inc. · FTM Mesh, Surgical
Cleared on Aug 24, 2001 after a 141-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 149 later devices descend from it.
- Decided
- Aug 24, 2001
- Review
- 141 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 0
149 later devices descend from it, 6 citing it directly.
- This deviceK011025 Fortaflex Surgical MeshOrganogenesis, Inc. · 2001
- Descendant · cites it directly · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- Descendant · cites it directly · 95 of its ownK013625 PermacolTissue Science Laboratories, Plc · 2002
- Descendant · 2 generations on · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- Descendant · cites it directly · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004
- Descendant · cites it directly · 51 of its ownK021056 PermacolTissue Science Laboratories, Plc · 2002
Showing 5 of 149 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 149 · See all- K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · cites it directly102descendants
- K013625PermacolTissue Science Laboratories, Plc · 2002 · cites it directly95descendants
- K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · 2 generations on93descendants
- K042809CuffpatchOrganogenesis, Inc. · 2004 · cites it directly72descendants
- K021056PermacolTissue Science Laboratories, Plc · 2002 · cites it directly51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011025 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2001 | — |
| +1 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| +1 | K013625 | Permacol | Tissue Science Laboratories, Plc | 2002 | — |
| +2 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| +1 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| +1 | K021056 | Permacol | Tissue Science Laboratories, Plc | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 9 | 0 |
| 2013 | 8 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 10 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 12 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (149)
See all 1496 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?
- Of its descendants, K020049 (Organogenesis, Inc., 2002) has gone furthest, with 102 descendants of its own.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K011025 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011025: Fortaflex Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011025
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026