# K092233: Surgimesh XD

- Pathway: 510(k) (Traditional)
- Applicant: Aspide Medical
- Decided: Jun 25, 2010 after 337 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: 4 generations back to K011251 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.
- K081010: Bard 3DMAX Mesh, Davol Inc., Sub. C. R. Bard, Inc. (2008) Summary page 2.
- K020007: Safyre Sling System, Promedon (2002) Summary page 1.

## Indications for use
The SURGIMESH®)XD mesh is recommended for reinforcement of hernia defects. The hernia repair is for an inguinal hernia. The SURGIMESH®XD implant is indicated for use via an extraperitoneal approach either by open or laparoscopic surgery.

Source page: https://510kreport.com/device/K092233
Methodology: https://510kreport.com/methodology