510(k) · Cleared
ClearedSurgisis Biodesign Tissue Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · FTM Mesh, Surgical
Cleared on Mar 21, 2008 as substantially equivalent to K062697 (Cook Biotech, Inc., 2006) and 1 other predicate after a 109-day review. Its family tree reaches back 9 generations to 1985. 8 later devices descend from it.
- Decided
- Mar 21, 2008
- Review
- 109 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K842066 (1985). 41 ancestors in all, the oldest K810428 (1981). 8 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations between
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- This deviceK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
- Descendant · 4 generations on · 1 of its ownK192616 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 8 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 6 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 5 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 4 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- This deviceK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · cites it directly4descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 2 generations on3descendants
- K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 3 generations on2descendants
- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · cites it directly2descendants
- K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −8 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −6 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −5 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −4 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −1 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 1 |
| 0 (this device) | K073391 | Surgisis Biodesign Tissue Graft | Cook Biotech, Inc. | 2008 | — |
| +1 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +2 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
| +3 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo… | Aziyo Biologics, Inc. | 2018 | 1 |
| +1 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
| +4 | K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K062697 | Sis Hernia Repair Device, Surgisis Gold Hernia Repair GraftSummary page 1…ect contact with viscera. The device is intended for one-time use. Predicate Devices: The SURGISIS® Biodesign Tissue Graft is substantially equivalent to itself (D.C. #K062697) acting as its own predicate and is substantially equivalent to Veritas® Collagen Matrix (D.C. #K062915) manufactured by Synovis… | 2006 |
| * | K062915 | Veritas Collagen MatrixSummary page 1…odesign Tissue Graft is substantially equivalent to itself (D.C. #K062697) acting as its own predicate and is substantially equivalent to Veritas® Collagen Matrix (D.C. #K062915) manufactured by Synovis Surgical Innovations. Device Description: The SURGISIS® Biodesign Tissue Graft is manufactured from por… | 2006 |
What descends from it? (8)
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 23 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 41 ancestors have a recall of any class.
- Of its descendants, K140306 (Cormatrix Cardiovascular, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K062697.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The SURGISIS® Biodesign Tissue Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect.
The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera.
This device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073391: Surgisis Biodesign Tissue Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073391
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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