# K071695: Kensey Nash Macropore Shield

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Dec 31, 2007 after 194 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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) Summary page 2.
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet, Macropore Biosurgery, Inc. (2003) Summary page 2.

## Indications for use
The Kensey Nash Bioresorbable Surgical Mesh 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. Tissue attachment to the bioresorbable surgical mesh is minimized in case of direct contact with the viscera.

Source page: https://510kreport.com/device/K071695
Methodology: https://510kreport.com/methodology