510(k) · Cleared
ClearedBiodesign Diaphragmatic Hernia Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · FTM Mesh, Surgical
Cleared on Mar 13, 2018 as substantially equivalent to K133011 (Cook Biotech, Inc., 2014) after a 267-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- Mar 13, 2018
- Review
- 267 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K881854 (1988). 36 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 9 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 5 generations between
- 3 generations backK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
- 2 generations backK120605 Permacol Surgical ImplantCovidien, LLC · 2012
- 1 generation backK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · Recalled
- This deviceK171817 Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018
Show all 9 generations
- Root · 9 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 8 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 7 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 6 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 5 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 4 generations backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- 3 generations backK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
- 2 generations backK120605 Permacol Surgical ImplantCovidien, LLC · 2012
- 1 generation backK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · Recalled
- This deviceK171817 Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −8 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −7 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −6 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −5 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −4 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| −3 | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | 3 |
| −2 | K120605 | Permacol Surgical Implant | Covidien, LLC | 2012 | — |
| −1 | K133011 | Diaphragmatic Hernia Graft | Cook Biotech, Inc. | 2014 | 1 |
| 0 (this device) | K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K133011 | Diaphragmatic Hernia GraftSummary page 4…21 CFR §878.3300 Product Code: OWV, FTM Regulatory Class: Class II III. PREDICATE DEVICE Biodesign® Diaphragmatic Hernia Graft (K133011, Cook Biotech Incorporated) IV. REFERENCE DEVICE Meso Bilayer Surgical Mesh (K132025, DSM Biomedical) V. DEVICE DESCRIPTION… | 2014 |
| † | K132025 | Meso Bilayer Surgical Mesh | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 36 ancestors have a recall of any class.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias.
The graft is supplied sterile and is intended for one time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171817: Biodesign Diaphragmatic Hernia Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171817
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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