# K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Sep 22, 2003 after 89 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: 1 generation back to K002699 (2001). 2 ancestors in all.
76 later devices descend from it; 9 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012025: Macropore Surgiwrap (TS), Macropore Biosurgery, Inc. (2001)
- K002699: Parietex Composite (Pco) Mesh, Medical Device Consultants, Inc. (2001)

## Most influential descendants
- K050332: Surgi-Wrap Mast Bioresorbable Sheet (2005), 36 descendants of its own
- K042811: Vivosorb Sheet, Model FS01 (2004), 22 descendants of its own
- K062558: Mesosfol Surgical Film (2007), 21 descendants of its own
- K090160: Suprathel Wound and Burn Dressing (2009), 18 descendants of its own
- K070894: Tephaflex Surgical Mesh (2007), 17 descendants of its own

## Indications for use
The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging 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/K031955
Methodology: https://510kreport.com/methodology