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 Mar 18, 2002 as substantially equivalent to K011025 (Organogenesis, Inc., 2001) and 1 other predicate after a 70-day review. Its family tree reaches back 5 generations to 1992. 102 later devices descend from it.
- Decided
- Mar 18, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). 102 later devices descend from it, 5 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 backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- This deviceK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- Descendant · cites it directly · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004
- Descendant · cites it directly · 49 of its ownK043388 Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005
- Descendant · 2 generations on · 44 of its ownK071065 Orthadapt BioimplantPegasus Biologics, Inc. · 2007
- Descendant · 2 generations on · 44 of its ownK052830 SportmeshArtimplant AB · 2006
- Descendant · 2 generations on · 41 of its ownK053562 Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K042809CuffpatchOrganogenesis, Inc. · 2004 · cites it directly72descendants
- K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005 · cites it directly49descendants
- K071065Orthadapt BioimplantPegasus Biologics, Inc. · 2007 · 2 generations on44descendants
- K052830SportmeshArtimplant AB · 2006 · 2 generations on44descendants
- K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006 · 2 generations on41descendants
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 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| +1 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| +1 | K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | 2005 | — |
| +2 | K071065 | Orthadapt Bioimplant | Pegasus Biologics, Inc. | 2007 | — |
| +2 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| +2 | K053562 | Zimmer Collagen Repair Patch | Tissue Science Laboratories, Plc | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K011025 | Fortaflex Surgical MeshSummary page 1…l Classification Name: Surgical Mesh (79FTM, 878.3300) Regulatory Class: Class I1 Predicate Device: The FortaFlex Surgical Mesh is equivalent to the material cleared in K011025 for use in surgical procedures for reinforcement of soft tissue. The relevant predicate device for the expanded indications for… | 2001 |
| * | K001738 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…rgical procedures for reinforcement of soft tissue. The relevant predicate device for the expanded indications for use is the Restore® Orthobiologic Soft Tissue Implant (K001738) manufactured by DePuy, Inc. Statement of Substantial Equivalence: The FortaFlex Surgical Mesh is substantially equivalent to th… | 2000 |
What descends from it? (102)
See all 1025 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 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K042809 (Organogenesis, Inc., 2004) has gone furthest, with 72 descendants of its own.
- 5 other devices also cite its predicate K011025.
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?
FortaFlex™ Surgical Mesh 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 also intended for reinforcement of the soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
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/K020049 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020049: Fortaflex Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020049
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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