Artelon Convenience Kits

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K260317 ↗

FDA Product Code

QWJ

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• FlexBand; FlexPatch; FlexBand Plus Open recall

  Class II

  FDA 510(k) K230316 Active Cleared 26 May 2023

• ATL Anchors Open recall

  Class II

  FDA 510(k) K200503 Active Cleared 2 Sep 2020

• FlexBand Plus

  Class II

  FDA 510(k) K192112 Active Cleared 27 Sep 2019

• What types of surgical procedures are the Artelon Convenience Kits designed to support with their resorbable mesh?

  The Artelon Convenience Kits are specifically designed for orthopedic use in ligament reinforcement procedures, such as ligament reconstruction or repair. The resorbable polymeric mesh provides structural support during surgery to aid tissue integration and stability, ensuring a smoother recovery process.

• Are the Artelon Convenience Kits meant for single-use or can they be reused after sterilization?

  The Artelon Convenience Kits are explicitly labeled as single-use devices. They are packaged for immediate sterile surgical use with no reprocessing required, ensuring safety and sterility for one-time application only.

• How should I store the Artelon Convenience Kits to maintain their sterility and functionality?

  The kits must be stored according to the manufacturer’s instructions to preserve sterility and integrity. Since they are single-use and pre-packaged for surgical environments, proper storage conditions—such as avoiding moisture, extreme temperatures, or contamination—are critical to maintaining their intended performance.

• What regulatory pathway was followed for the FDA clearance of the Artelon Convenience Kits, and what class does this device fall under?

  The Artelon Convenience Kits received FDA clearance through a 510(k) submission (K260317), classified as Substantially Equivalent (SESE) under the traditional review pathway. They are categorized as Class II devices under FDA regulation 878.3300, indicating a moderate level of regulatory oversight for surgical meshes.

• What special handling or preparation is required before using the Artelon Convenience Kits in surgery?

  No additional reprocessing or preparation is required beyond adhering to standard sterile surgical protocols. The kits are pre-packaged for immediate use in sterile environments, so they can be opened and deployed directly during ligament reinforcement procedures without further manipulation.