# K120025: Surgimesh XB - Skirted

- Pathway: 510(k) (Special)
- Applicant: Aspide Medical
- Decided: Jun 26, 2012 after 175 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: 6 generations back to K931386 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072974: Surgimesh XB, Aspide Medical (2008) Summary page 2.
- K061445: Surgimesh WN, Aspide Medical (2007) Summary page 1.
- K992189: Gore-Tex Dualmesh Biomaterial, W. L. Gore & Associates, Inc. (1999) Summary page 1.
- K110816: Parietex Optimized Composite Mesh (Pco-Osx References), Sofradim Production (2011) Summary page 2.

## Indications for use
The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair. The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera

Source page: https://510kreport.com/device/K120025
Methodology: https://510kreport.com/methodology