510(k) · Cleared
ClearedGraft Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organogenesis, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Aug 1, 1997 as substantially equivalent to K923657 (Bio-Vascular, Inc., 1992) after a 169-day review. Its family tree reaches back 1 generation to 1992. 285 later devices descend from it.
- Decided
- Aug 1, 1997
- Review
- 169 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923657 (1992). 285 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK923657 Supple Peri-GuardBio-Vascular, Inc. · 1992
- This deviceK970561 Graft PatchOrganogenesis, Inc. · 1997
- Descendant · cites it directly · 284 of its ownK980431 SurgisisCook Biotech, Inc. · 1998
- Descendant · 2 generations on · 204 of its ownK992159 Surgisis SlingCook Biotech, Inc. · 1999
- Descendant · cites it directly · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- Descendant · 2 generations on · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
Showing 5 of 285 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 285 · See all- K980431SurgisisCook Biotech, Inc. · 1998 · cites it directly284descendants
- K992159Surgisis SlingCook Biotech, Inc. · 1999 · 2 generations on204descendants
- K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · cites it directly173descendants
- K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 2 generations on102descendants
- K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · 2 generations on93descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923657 | Supple Peri-Guard | Bio-Vascular, Inc. | 1992 | — |
| 0 (this device) | K970561 | Graft Patch | Organogenesis, Inc. | 1997 | — |
| +1 | 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 | — |
| +2 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| +2 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 11 | 0 |
| 2006 | 12 | 0 |
| 2007 | 13 | 0 |
| 2008 | 17 | 0 |
| 2009 | 15 | 0 |
| 2010 | 10 | 0 |
| 2011 | 13 | 0 |
| 2012 | 12 | 0 |
| 2013 | 12 | 0 |
| 2014 | 15 | 0 |
| 2015 | 8 | 0 |
| 2016 | 17 | 0 |
| 2017 | 19 | 0 |
| 2018 | 12 | 0 |
| 2019 | 8 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 11 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923657 | Supple Peri-GuardSummary page 2….S. commercial distribution. Examples of other surgical meshes which have been cleared for commercial distribution include the Supple Peri- guard® by Bio-Vascular, Inc. (K923657), and Vicryl surgical mesh by Ethicon, Inc. (K810218). Determination of substantial equivalence for this product was based on de… | 1992 |
| Kept off the family tree | K810218 | FDA’s K810218 is Prefilled Nebulizer Our OCR of the scanned summary read K810218, FDA’s number for Prefilled Nebulizer (Corpak Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vicryl surgical mesh”. Kept off the family tree. Summary page 2…al meshes which have been cleared for commercial distribution include the Supple Peri- guard® by Bio-Vascular, Inc. (K923657), and Vicryl surgical mesh by Ethicon, Inc. (K810218). Determination of substantial equivalence for this product was based on descriptive information about the design, materials, an… | 1981 |
What descends from it? (285)
See all 2855 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?
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
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/K970561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970561: Graft Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970561
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