# K081272: Porcine Surgical Mesh; Dermal Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, LLC
- Decided: Jul 31, 2008 after 87 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921895 (1992). 45 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993459: Modification to Brennen Biosynthetic Surgical Mesh Matrix, Advanced Uroscience, Inc. (1999) Summary page 1.
- K030460: Modification to Brennen Biosynthetic Surgical Mesh Matrix, Brennen Medical, Inc. (2003) Summary page 1.
- K021160: Dermmatrix Surgical Mesh, Carbon Medical Technologies, Inc. (2002) Summary page 1.
- K013625: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.
- K071807: Orthomend Soft Tissue Matrix, Tei Biosciences, Inc. (2007) Summary page 1.

## Most influential descendants
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own
- K151177: XenMatrix AB Surgical Graft (2015), 1 descendant of its own
- K111436: Porcine Surgical Mesh, Porcine Dermal Matrix (2011), 1 descendant of its own
- K162193: XenMatrix AB Surgical Graft (2016), 0 descendants of its own
- K140501: Xenmatrix Surgical Graft (2014), 0 descendants of its own

## Recalls of this device
- Jan 7, 2011 · Not classified · Z-1381-2011: 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: 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: 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: 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.

## 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, 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.

Source page: https://510kreport.com/device/K081272
Methodology: https://510kreport.com/methodology