510(k) · Cleared
Recalled · 2011Porcine Surgical Mesh; Dermal Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brennen Medical, LLC · FTM Mesh, Surgical
Cleared on Jul 31, 2008 as substantially equivalent to K993459 (Advanced Uroscience, Inc., 1999) and 4 other predicates after an 87-day review. Its family tree reaches back 9 generations to 1992. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 31, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 9 generations to K921895 (1992). 45 ancestors in all, the oldest K830889 (1983). 6 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 1 generation backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- This deviceK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008
- Descendant · cites it directly · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK151177 XenMatrix AB Surgical GraftC. R. Bard · 2015
- Descendant · cites it directly · 1 of its ownK111436 Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK162193 XenMatrix AB Surgical GraftC. R. Bard · 2016
- Descendant · cites it directly · 0 of its ownK140501 Xenmatrix Surgical GraftC. R. Bard · 2014
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 1 generation backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- This deviceK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · cites it directly2descendants
- K151177XenMatrix AB Surgical GraftC. R. Bard · 2015 · 2 generations on1descendant
- K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011 · cites it directly1descendant
- K162193XenMatrix AB Surgical GraftC. R. Bard · 2016 · 2 generations on0descendants
- K140501Xenmatrix Surgical GraftC. R. Bard · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −2 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −1 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| 0 (this device) | K081272 | Porcine Surgical Mesh; Dermal Matrix | Brennen Medical, LLC | 2008 | — |
| +1 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
| +2 | K151177 | XenMatrix AB Surgical Graft | C. R. Bard | 2015 | — |
| +1 | K111436 | Porcine Surgical Mesh, Porcine Dermal Matrix | Brennen Medical, LLC | 2011 | — |
| +2 | K162193 | XenMatrix AB Surgical Graft | C. R. Bard | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (5)
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 |
|---|---|---|---|
| * | K993459 | Modification to Brennen Biosynthetic Surgical Mesh MatrixSummary page 1…ICATE DEVICES Company Device 510(k) No. Date Cleared Advanced Uroscience Porcine Surgical Mesh K993459 11/05/1999 Brennen Medical Porcine Surgical Mesh K030460 03/07/2003 Brennen Medica… | 1999 |
| * | K030460 | Modification to Brennen Biosynthetic Surgical Mesh MatrixSummary page 1…Date Cleared Advanced Uroscience Porcine Surgical Mesh K993459 11/05/1999 Brennen Medical Porcine Surgical Mesh K030460 03/07/2003 Brennen Medical DermMatrix K021160 06/12/2002 Tissue Science… | 2003 |
| * | K021160 | Dermmatrix Surgical MeshSummary page 1…11/05/1999 Brennen Medical Porcine Surgical Mesh K030460 03/07/2003 Brennen Medical DermMatrix K021160 06/12/2002 Tissue Sciences Labs Permacol/Pelvicol K013625 01/17/2002 TEl Bioscience… | 2002 |
| * | K013625 | PermacolSummary page 1…03/07/2003 Brennen Medical DermMatrix K021160 06/12/2002 Tissue Sciences Labs Permacol/Pelvicol K013625 01/17/2002 TEl Biosciences SurgiMend K071807 08/06/2007 16.4 DEVICE DESC… | 2002 |
| * | K071807 | Orthomend Soft Tissue MatrixSummary page 1…06/12/2002 Tissue Sciences Labs Permacol/Pelvicol K013625 01/17/2002 TEl Biosciences SurgiMend K071807 08/06/2007 16.4 DEVICE DESCRIPTION Porcine Dermal Matrix is a prescription, sterile, pyrogen free, single u… | 2007 |
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2011 | Not classified | Z-1381-2011 | Process control | Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria. |
| Jan 7, 2011 | Not classified | Z-1379-2011 | Process control | Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria. |
| Jan 7, 2011 | Not classified | Z-1380-2011 | Process control | Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria. |
| Jan 7, 2011 | Not classified | Z-1382-2011 | Process control | Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 45 ancestors have a recall of any class.
- Of its descendants, K133223 (C.R. Bard, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K993459.
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?
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery; Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.…
Read the full statement (116 words)
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery; Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081272: Porcine Surgical Mesh; Dermal Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081272
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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