ThermoFX Mesh

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K003757 ↗

FDA Product Code

JEY

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• Meniscus Arrow Sheath #CN1000A; Smartscrew Acl Sheath #SSA2000A

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See all devices from Bionx Implants, Inc. →

• What types of procedures is the ThermoFX Mesh designed to support in dental and maxillofacial surgery?

  The ThermoFX Mesh is specifically designed for internal fixation in dental and maxillofacial applications, providing mechanical support to stabilize bone segments during the healing process. This makes it suitable for procedures requiring rigid fixation, such as fractures, reconstructions, or segmental defects in the jaw or facial bones.

• Is the ThermoFX Mesh intended for reuse, or is it meant to be used only once?

  The ThermoFX Mesh is explicitly intended for single-use only. It is supplied sterile, ensuring safety and reliability for one-time surgical application, which aligns with best practices for medical devices in controlled clinical settings.

• How many different sizes or variants of the ThermoFX Mesh are available, and how can I identify them?

  The ThermoFX Mesh comes in multiple sizes and variants, each identified by unique FEI numbers. Over 70 distinct FEI numbers are listed, such as 3011302692, 3003322138, and 1000307073, allowing for tailored selection based on specific clinical needs. These identifiers help ensure the correct size is chosen for the procedure.

• What regulatory pathway does the ThermoFX Mesh follow, and what does this mean for its use?

  The ThermoFX Mesh follows the FDA 510(k) clearance pathway, classified as a Class II dental device under product code JEY. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness in dental and maxillofacial applications. Its clearance (K003757) confirms it adheres to regulatory requirements for use in controlled clinical settings.

• How should the ThermoFX Mesh be stored to maintain its sterility and integrity?

  Since the ThermoFX Mesh is supplied sterile, it should be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment, protected from moisture, extreme temperatures, and physical damage. Always follow manufacturer guidelines for storage duration and conditions to ensure optimal performance and safety.