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.

• • Ongoing Z-0587-2024 FDA Class II ·initiated 21 Nov 2023

  Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

• • Ongoing Z-0024-2022 FDA Class II ·initiated 30 Aug 2021

  Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

• • Ongoing Z-2926-2020 FDA Class II ·initiated 10 Aug 2020

  The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

• • Terminated Z-2966-2018 FDA Class II ·initiated 13 Jul 2018 ·on shared 510(k) K152217

  Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

• 2 recalls, same reason

  • Terminated Z-0200-2018 FDA Class II ·initiated 16 May 2017
  • Terminated Z-0201-2018 FDA Class II ·initiated 16 May 2017

  Possible inner labeling and packaged device not matching the outer label on the box.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Vantage® Total Ankle EUDAMED

Vantage GUDID

Generic Name

Surgical screwdriver, reusable

Orthopaedic osteotome

Model / Ref / Catalog

351-93-02, 351-10-33, Vantage

Primary DI / UDI-DI

10885862290809, 10885862566539

Basic UDI-DI

10885862100182P9, 10885862100176PE

Direct Marketing DI

10885862290809

510(k) Number

K232002 ↗ 510(k)

K152217 ↗ GUDID

FDA Product Code

HSN, HXX

EMDN Code

L091199, L090401

GMDN Term

Surgical screwdriver, reusable

Orthopaedic osteotome

Device Class

Class I EUDAMEDGUDID

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3110 510(k)GUDID

888.4540 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 Vantage® Total Ankle System designed to help, and how does it restore function?

  The Vantage® Total Ankle System is designed for patients with damaged or arthritic ankle joints who require joint replacement surgery. As a semi-constrained, cemented prosthesis made of metal and polymer components, it is intended to restore mobility and function by replacing the damaged joint surfaces, allowing for improved weight-bearing and movement. This system is specifically engineered to fit the anatomical needs of patients undergoing orthopedic ankle replacement surgeries.

• Is the Vantage® Total Ankle System intended for single-use or can it be reused after sterilization?

  The Vantage® Total Ankle System is supplied as a reusable surgical implant, but it is non-sterile and must undergo sterilization prior to use. This follows standard medical device sterilization protocols to ensure safety and efficacy for subsequent procedures. Always follow manufacturer guidelines for sterilization to maintain device integrity.

• How do I determine the correct size or variant for a patient’s anatomy?

  The Vantage® Total Ankle System comes in multiple sizes and variants, each identified by unique FEI numbers and registration numbers (e.g., 3010375065, 3009923578). These identifiers ensure compatibility with different patient anatomies and surgical requirements. Consult the manufacturer’s sizing guides or surgical planning tools to select the appropriate variant based on preoperative imaging and measurements.

• What regulatory pathways does the Vantage® Total Ankle System follow, and how does this affect procurement?

  The Vantage® Total Ankle System is authorized under FDA 510K and MDR (Medical Device Regulation) pathways, indicating compliance with both U.S. and European Union regulatory standards. This means it has undergone rigorous evaluation for safety and performance, ensuring it meets the necessary requirements for use in orthopedic surgeries. When procuring, verify that the device carries the correct registration numbers (e.g., 3010375065) and FEI numbers to confirm regulatory compliance and traceability.

• What storage requirements should be followed for the Vantage® Total Ankle System before sterilization?

  Since the Vantage® Total Ankle System is non-sterile and intended for reuse, it must be stored in a clean, dry environment protected from contamination, moisture, and physical damage. Follow manufacturer instructions for packaging and storage conditions to preserve the integrity of the metal and polymer components until sterilization. Avoid exposure to extreme temperatures or direct sunlight, as these could compromise the device’s performance.