# K050332: Surgi-Wrap Mast Bioresorbable Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Mast Biosurgery USA, Inc.
- Decided: May 27, 2005 after 106 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). 5 ancestors in all.
36 later devices descend from it; 5 cite it directly.
0 of 42 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 3.
- K012025: Macropore Surgiwrap (TS), Macropore Biosurgery, Inc. (2001) Summary page 3.
- K031225: Timesh Also Known as Timesh-TC, Models 6000001 & 6000004, Gfe Medizintechnik GmbH (2003) Summary page 3.
- K010533: Biosling - Bioabsorbable Polymer Sling & Surgical Mesh, Injectx, Inc. (2001) Summary page 3.

## Most influential descendants
- K070894: Tephaflex Surgical Mesh (2007), 17 descendants of its own
- K061473: Surgi-Wrap Mast Bioresorbable Sheet (2006), 13 descendants of its own
- K063648: Surgi-Wrap Mast Tendon Sheet (2007), 12 descendants of its own
- K072190: Ortho-Wrap Bioresorbable Sheet (2008), 10 descendants of its own
- K083823: Securian Tissue Reinforcement Matrix (2009), 9 descendants of its own

## Indications for use
The Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, 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. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse, repair, reconstruction of the pelvic floor and sacral colposuspension. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the viscera. The device is indicated for open and laparoscopic procedures. Laparoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

Source page: https://510kreport.com/device/K050332
Methodology: https://510kreport.com/methodology