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Xylos Surgical Mesh

by Xylos Corporation 510(k)

Active United States

510(k) K023237

Overview

Xylos Surgical Mesh is a surgical mesh device intended for implantation to reinforce soft tissue. It is used in procedures including the repair of abdominal and thoracic wall defects, muscle flap reinforcement, prolapse repair, pelvic floor reconstruction, hernia repair, and suture line reinforcement.

This device is intended for one-time use and is authorized under FDA 510(k) clearance. It is also indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, such as the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023237 Date18 Mar 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the intended use of Xylos Surgical Mesh?

    This device is intended for implantation to reinforce soft tissue. It is indicated for procedures including abdominal and thoracic wall defect repair, muscle flap reinforcement, prolapse repair, pelvic floor reconstruction, hernia repair, suture line reinforcement, and the reinforcement of soft tissues during tendon repair surgery.

  • Is Xylos Surgical Mesh intended for reuse?

    No, this device is intended for one-time use only. It should not be reprocessed or reused after the initial surgical procedure.

  • What is the regulatory status of this device?

    Xylos Surgical Mesh is authorized under FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to a predicate device.