# K232595: Kinos Axiom Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: Nov 28, 2023 after 95 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). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192778: Kinos Axiom Total Ankle System, Kinos Medical (2020) Summary page 6.
- K140749: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2014) Summary page 6.

## Most influential descendants
- K241482: Kinos Total Ankle System (2024), 2 descendants of its own
- K242868: Kinos Total Ankle System (2024), 1 descendant of its own
- K252454: Kinos Total Ankle System (2025), 0 descendants of its own

## Indications for use
The Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Axiom Total Ankle System is intended for cement use only.

Source page: https://510kreport.com/device/K232595
Methodology: https://510kreport.com/methodology