# K152217: Exactech Vantage Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 10, 2016 after 216 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K920802 (1992). 10 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090076: Salto Talaris Total Ankle Prosthesis, Tornier (2009) Summary page 4.
- K123954: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K140749: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Most influential descendants
- K171004: Hintermann Series H2 Total Ankle System (2017), 2 descendants of its own
- K240475: Hintermann Series H2 Total Ankle System (2024), 0 descendants of its own
- K230717: Exactech® Vantage® Total Ankle System (2023), 0 descendants of its own
- K232002: Vantage® Total Ankle System (2023), 0 descendants of its own
- K230462: OPTIX H2 Patient Specific Instrument System (2023), 0 descendants of its own

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0587-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Aug 30, 2021 · Class II · Z-0024-2022: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- Aug 10, 2020 · Class II · Z-2926-2020: 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
- Jul 13, 2018 · Class II · Z-2966-2018: 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
- May 16, 2017 · Class II · Z-0200-2018: Possible inner labeling and packaged device not matching the outer label on the box.
- May 16, 2017 · Class II · Z-0201-2018: Possible inner labeling and packaged device not matching the outer label on the box.

## Indications for use
The Vantage™ Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Vantage™ Total Ankle System is indicated for cemented use only.

Source page: https://510kreport.com/device/K152217
Methodology: https://510kreport.com/methodology