# K232002: Vantage® Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Sep 11, 2023 after 68 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K920802 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152217: Exactech Vantage Total Ankle System, Exactech, Inc. (2016) Summary page 4.

## 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/K232002
Methodology: https://510kreport.com/methodology