Xylos Surgical Mesh Modification
by Xylos Corporation 510(k)
Active
510(k) K081882
Overview
This device is a surgical mesh, classified under the FDA’s Mesh, Surgical category (product code FTM). It is a non-absorbable biomaterial designed to support tissue integration and reinforcement in surgical applications, particularly in general and plastic surgery. The modification retains the core properties of the original Xylos Surgical Mesh, including a microporous structure intended to facilitate rapid tissue incorporation and minimize foreign body response.
The mesh is supplied as a sterile, single-use product in double-pouch packaging. It is intended for use in operative settings where tissue reinforcement is required, such as hernia repair or soft tissue augmentation. Regulatory clearance under FDA 510(k) (K081882) confirms its classification as Class II, with a Special clearance type. No additional regulatory status beyond the stated FDA authorization is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081882 | Date11 Jul 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Modification to Xylos Surgical Mesh
- 510(k) Number
- FDA Product Code
- FTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Xylos Corporation
Questions
What is the Xylos Surgical Mesh Modification used for?
The Xylos Surgical Mesh Modification is a non-absorbable biomaterial intended to support tissue integration and reinforcement during surgical procedures. It is primarily used in general and plastic surgery applications, such as hernia repair or soft tissue augmentation, where additional structural support is required. Its microporous structure is engineered to promote rapid tissue incorporation and minimize foreign body reactions, ensuring better long-term integration with surrounding tissues.
How is the Xylos Surgical Mesh Modification supplied?
This mesh modification is supplied as a sterile, single-use product in double-pouch packaging. The sterile packaging ensures contamination control before use, and the single-use designation prevents cross-contamination between patients, adhering to best practices for surgical materials.
Is the Xylos Surgical Mesh Modification reusable?
No, the Xylos Surgical Mesh Modification is explicitly designed for single-use only. Single-use products are intended to be used once per patient and then discarded to maintain sterility and reduce infection risks. Reusing this mesh could compromise its integrity and introduce contamination, posing potential risks to patient safety.
What regulatory approval does the Xylos Surgical Mesh Modification hold?
The Xylos Surgical Mesh Modification has received FDA clearance under the 510(k) pathway, specifically with clearance number K081882. This classification confirms it as a Class II device with a Special clearance type, indicating it has been evaluated for safety and effectiveness in its intended surgical applications. The clearance is specific to its use in tissue reinforcement and does not imply broader regulatory status beyond the stated authorization.
How should the Xylos Surgical Mesh Modification be stored?
The mesh modification should be stored in its original, unopened double-pouch packaging to preserve sterility. It should be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Follow manufacturer guidelines for expiration dates and avoid storing it in areas prone to contamination, such as near chemicals or cleaning agents. Proper storage ensures the mesh remains effective and safe for its intended surgical use.