# K240591: restor3d Kinos Axiom Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D, Inc.
- Decided: Apr 29, 2024 after 59 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: 8 generations back to K984290 (1999). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123954: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2013) Summary page 5.
- K182878: Integra Salto Total Ankle System, Ascension Orthopedics (2018) Summary page 5.

## Indications for use
The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.

Source page: https://510kreport.com/device/K240591
Methodology: https://510kreport.com/methodology