# K090880: Xylos Porous Surgical Mesh

- Pathway: 510(k) (Special)
- Applicant: Xylos Corporation
- Decided: May 27, 2009 after 57 days
- Product code: FTM (Mesh, Surgical)
- 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: 5 generations back to K842066 (1985). 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)
- K081882: Modification to Xylos Surgical Mesh, Xylos Corporation (2008) Summary page 2.

## Indications for use
This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Source page: https://510kreport.com/device/K090880
Methodology: https://510kreport.com/methodology