Vantage Total Ankle System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Full name

Exactech® Vantage® Total Ankle System

Trade Name

Vantage® Total Ankle EUDAMED

ExactechGPS Ankle Application GUDID

Generic Name

Orthopaedic stereotactic surgery system

Model / Ref / Catalog

Vantage EUDAMED

03-GNB-BF-0011 EUDAMED

03-GNB-CB-0001 GUDID

Primary DI / UDI-DI

10885862631305

Basic UDI-DI

10885862100169PH

510(k) Number

K230717 ↗ 510(k)

K232521 ↗ GUDID

FDA Product Code

HSN 510(k)

OLO GUDID

EMDN Code

L091199 Orthopaedic prosthetics instruments, reusable - other

GMDN Term

Orthopaedic stereotactic surgery system

Device Class

Class I EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3110 510(k)

882.4560 GUDID

EU market of registration

Spain

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

See all devices from Exactech, Inc. →

• What types of patients is the Exactech® Vantage® Total Ankle System intended to help, and how does it restore ankle function?

  The Exactech® Vantage® Total Ankle System is designed for patients with damaged or arthritic ankle joints who require joint replacement to restore mobility and function. Its semi-constrained, fixed-bearing metal and polymer design mimics natural ankle mechanics, providing stability and improved movement for those suffering from degenerative joint conditions or trauma.

• Is the Exactech® Vantage® Total Ankle System reusable, or is it meant for single-use only?

  The Exactech® Vantage® Total Ankle System is supplied as a sterile, single-use device. This ensures patient safety and sterility during surgical procedures, as reuse is not recommended or intended by the manufacturer.

• What storage and handling guidelines should be followed to maintain the device’s sterility and integrity?

  The manufacturer provides specific storage and handling guidelines to preserve sterility and device integrity. These instructions must be followed strictly to ensure the components remain uncontaminated and functional until use in surgery.

• Does the Exactech® Vantage® Total Ankle System come in multiple sizes, and how does this accommodate different patient anatomies?

  Yes, the system includes standardized sizes tailored to accommodate varying patient anatomies. The range of sizes ensures compatibility with different ankle dimensions, allowing for a precise and well-fitted implant during surgery.

• Can the Exactech® Vantage® Total Ankle System be used in MRI environments, and what special considerations should be taken during surgery?

  No, the components of the Exactech® Vantage® Total Ankle System are MRI-unsafe, meaning they should not be used in MRI environments. Specialized instrumentation is required for implantation, and surgeons must ensure proper handling and positioning to avoid complications.