# K061473: Surgi-Wrap Mast Bioresorbable Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Mast Biosurgery USA, Inc.
- Decided: Sep 21, 2006 after 114 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002699 (2001). 9 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053655: Tendon Wrap Tendon Protector, Integra LifeSciences Corporation (2006) Summary page 3.
- K050332: Surgi-Wrap Mast Bioresorbable Sheet, Mast Biosurgery USA, Inc. (2005) Summary page 3.

## Most influential descendants
- 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
- K111584: Xylos Macro-Porous Surgical Mesh (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own

## Recalls of this device
- Aug 26, 2014 · Class II · Z-1076-2015: The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 

## Indications for use
The Surgi-Wrap MAST Bioresorbable Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

Source page: https://510kreport.com/device/K061473
Methodology: https://510kreport.com/methodology