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 May 10, 2002 as substantially equivalent to K970561 (Organogenesis, Inc., 1997) and 1 other predicate after a 35-day review. Its family tree reaches back 3 generations to 1992. 42 later devices descend from it.
- Decided
- May 10, 2002
- Review
- 35 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921895 (1992). 6 ancestors in all, the oldest K830889 (1983). 42 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
- This deviceK021105 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- Descendant · cites it directly · 39 of its ownK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- Descendant · 2 generations on · 13 of its ownK071016 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK083266 Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009
- Descendant · 3 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- Descendant · 4 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003 · cites it directly39descendants
- K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2007 · 2 generations on13descendants
- K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009 · 2 generations on12descendants
- K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 3 generations on12descendants
- K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| 0 (this device) | K021105 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| +1 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| +2 | K071016 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2007 | — |
| +2 | K083266 | Gore Bio-a Fistula Plug | W. L. Gore & Associates, Inc. | 2009 | — |
| +3 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| +4 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K970561 | Graft PatchSummary page 1…he device is similar to predicate collagen-based Surgical Mesh devices previously cleared for commercial distribution. The relevant predicate devices include GraftPatch (K970561) manufactured by Organogenesis Inc. and Surgisis (X980431) manufactured by Cook Biotech, Incorporated. Statement of Substantial… | 1997 |
| * | K980431 | SurgisisSummary page 1…esh devices previously cleared for commercial distribution. The relevant predicate devices include GraftPatch (K970561) manufactured by Organogenesis Inc. and Surgisis (X980431) manufactured by Cook Biotech, Incorporated. Statement of Substantial Equivalence: FortaGen 1is substantially equivalent to the… | 1998 |
What descends from it? (42)
See all 422 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 10 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K033671 (W. L. Gore & Associates, Inc., 2003) has gone furthest, with 39 descendants of its own.
- 4 other devices also cite its predicate K970561.
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 | — |
What is it indicated for?
FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
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/K021105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021105: Fortaflex Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021105
Report an extraction error
Are you the manufacturer?
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