# K111436: Porcine Surgical Mesh, Porcine Dermal Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, LLC
- Decided: Oct 14, 2011 after 143 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921895 (1992). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081272: Porcine Surgical Mesh; Dermal Matrix, Brennen Medical, LLC (2008) Summary page 1.
- K030460: Modification to Brennen Biosynthetic Surgical Mesh Matrix, Brennen Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K113866: Porcine Dermal Xenografts Porcine Dermal Matrix (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K111436
Methodology: https://510kreport.com/methodology