# K023237: Xylos Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Xylos Corporation
- Decided: Mar 18, 2003 after 172 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: 3 generations back to K842066 (1985). 8 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 1.
- K962530: Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (1996) Summary page 1.
- K974251: X-Cell Wound Dressing, Xylos Corporation (1998) Summary page 1.

## Most influential descendants
- K081882: Modification to Xylos Surgical Mesh (2008), 11 descendants of its own
- K083823: Securian Tissue Reinforcement Matrix (2009), 9 descendants of its own
- K111584: Xylos Macro-Porous Surgical Mesh (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own

## 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/K023237
Methodology: https://510kreport.com/methodology