# K042811: Vivosorb Sheet, Model FS01

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics B.V.,
- Decided: Nov 8, 2004 after 27 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 2 generations back to K002699 (2001). 4 ancestors in all.
22 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.
- K032673: Immix Plastifilm, Osteobiologics, Inc. (2003) Summary page 1.

## Most influential descendants
- K062558: Mesosfol Surgical Film (2007), 21 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K042811
Methodology: https://510kreport.com/methodology