# K072974: Surgimesh XB

- Pathway: 510(k) (Traditional)
- Applicant: Aspide Medical
- Decided: Aug 18, 2008 after 301 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931386 (1993). 26 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061445: Surgimesh WN, Aspide Medical (2007) Summary page 1.
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh, American Medical Systems, Inc. (2000) Summary page 1.
- K010228: Gore-Tex Dualmesh Plus Biomaterial with Holes, W. L. Gore & Associates, Inc. (2001) Summary page 1.
- K033814: Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007, C.R. Bard, Inc. (2004) Summary page 1.
- K061754: Bard Composite L/P Mesh, Davol Inc., Sub. C. R. Bard, Inc. (2006) Summary page 1.

## Most influential descendants
- K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab (2010), 1 descendant of its own
- K120025: Surgimesh XB - Skirted (2012), 0 descendants of its own
- K112567: Biomerix Assure (2011), 0 descendants of its own

## Recalls of this device
- Aug 12, 2022 · Class II · Z-1985-2025: Potential presence of residual adhesive material on the mesh surface.
- Aug 12, 2022 · Class II · Z-1984-2025: Potential presence of residual adhesive material on the mesh surface.

## Indications for use
The SURGIMESH®XB 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/K072974
Methodology: https://510kreport.com/methodology