510(k) · Cleared
ClearedXenmatrix Surgical Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C. R. Bard · FTM Mesh, Surgical
Cleared on Apr 28, 2014 as substantially equivalent to K081272 (Brennen Medical, LLC, 2008) after a 60-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Apr 28, 2014
- Review
- 60 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921895 (1992). 46 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 2 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 1 generation backK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · Recalled
- This deviceK140501 Xenmatrix Surgical GraftC. R. Bard · 2014
Show all 10 generations
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 5 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 4 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 3 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 2 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 1 generation backK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · Recalled
- This deviceK140501 Xenmatrix Surgical GraftC. R. Bard · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −9 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −7 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −6 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −4 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −3 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −2 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −1 | K081272 | Porcine Surgical Mesh; Dermal Matrix | Brennen Medical, LLC | 2008 | 4 |
| 0 (this device) | K140501 | Xenmatrix Surgical Graft | C. R. Bard | 2014 | — |
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 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K081272 | Porcine Surgical Mesh; Dermal MatrixSummary page 1…Regulation Number: 21 CFR 878.3300 Device Class: 111 Panel: General & Plastic Surgery Predicate Device: K081272 "Porcine Dermal Matrix Surgical Mesh" FDA cleared on 31 July 2008 from Brennen Medical, LLC . Davol, Inc. acquired the 5 10(k) pr… | 2008 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 46 ancestors have a recall of any class.
- 2 other devices also cite its predicate K081272.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140501 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140501: Xenmatrix Surgical Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140501
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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