# K062558: Mesosfol Surgical Film

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jun 20, 2007 after 294 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: 3 generations back to K002699 (2001). 5 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet, Macropore Biosurgery, Inc. (2003) Summary page 1.
- K042811: Vivosorb Sheet, Model FS01, Polyganics B.V., (2004) Summary page 1.

## Most influential descendants
- K090160: Suprathel Wound and Burn Dressing (2009), 18 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K142879: BTM Wound Dressing (2015), 5 descendants of its own
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (2017), 4 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own

## Indications for use
Mesofol® Surgical Sheet is indicated when temporary wound support is required to reinforce soft tissues where weakness exists, or in conjunction with hernia repair or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective sheet minimizes tissue attachment to the device in case of direct contact with the viscera.

Source page: https://510kreport.com/device/K062558
Methodology: https://510kreport.com/methodology