510(k) · Cleared
ClearedPorcine Surgical Mesh, Porcine 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 Oct 14, 2011 as substantially equivalent to K081272 (Brennen Medical, LLC, 2008) and 1 other predicate after a 143-day review. Its family tree reaches back 10 generations to 1992. 1 later device descends from it.
- Decided
- Oct 14, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K921895 (1992). 46 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- 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 deviceK111436 Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011
- Descendant · cites it directly · 0 of its ownK113866 Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC · 2012
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 deviceK111436 Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC · 2012 · cites it directly0descendants
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) | K111436 | Porcine Surgical Mesh, Porcine Dermal Matrix | Brennen Medical, LLC | 2011 | — |
| +1 | K113866 | Porcine Dermal Xenografts Porcine Dermal Matrix | Brennen Medical, LLC | 2012 | — |
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 |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K081272 | Porcine Surgical Mesh; Dermal MatrixSummary page 1…Company Device 510(k) No. Date Cleared Brennen Medical Porcine Surgical Mesh K08 1272 07/31/2008 Brennen Medical Porcine Surgical Mesh K030460 03/07/2003 DE… | 2008 |
| * | K030460 | Modification to Brennen Biosynthetic Surgical Mesh MatrixSummary page 1…Brennen Medical Porcine Surgical Mesh K08 1272 07/31/2008 Brennen Medical Porcine Surgical Mesh K030460 03/07/2003 DEVICE DESCRIPTION Porcine Dermal Matrix is a prescription, sterile, single use, hydrated, non-c… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113866 | Porcine Dermal Xenografts Porcine Dermal Matrix | 2012 | 0 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 46 ancestors have a recall of any class.
- Of its descendants, K113866 (Brennen Medical, LLC, 2012) has gone furthest, with 0 descendants of its own.
- 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. 2011, 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, quadriceps, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111436 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111436: Porcine Surgical Mesh, Porcine 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/K111436
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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