# K061445: Surgimesh WN

- Pathway: 510(k) (Traditional)
- Applicant: Aspide Medical
- Decided: Feb 1, 2007 after 253 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: 3 generations back to K011251 (2001). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992556: Permacol, Tissue Science Laboratories, Plc (2000) Summary page 1.
- K033814: Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007, C.R. Bard, Inc. (2004) Summary page 1.
- K031767: Mentor Obtape Trans-Obturator Tape, Mentor Corp. (2003) Summary page 1.

## Most influential descendants
- K072974: Surgimesh XB (2008), 3 descendants of its own
- 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
- K092233: Surgimesh XD (2010), 0 descendants of its own

## Recalls of this device
- Aug 12, 2022 · Class II · Z-1983-2025: Potential presence of residual adhesive material on the mesh surface.
- Aug 12, 2022 · Class II · Z-1986-2025: Potential presence of residual adhesive material on the mesh surface.

## Indications for use
The SURGIMESH®WN implant is recommended for reinforcement of hernia defects. The hernia repair could be, for example, inguinal hernia, femoral or crural hernia or ventral hernia. The SURGIMESH®WN implant is indicated for use via an extraperitoneal approach either by open or laproscopic surgery.

Source page: https://510kreport.com/device/K061445
Methodology: https://510kreport.com/methodology