# K230717: Exactech® Vantage® Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 12, 2023 after 211 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/K230717
Methodology: https://510kreport.com/methodology