# K252454: Kinos Total Ankle System

- Pathway: 510(k) (Special)
- Applicant: Restor3D
- Decided: Sep 3, 2025 after 30 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: 10 generations back to K920802 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242868: Kinos Total Ankle System, Restor3D (2024) Summary page 6.

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

Source page: https://510kreport.com/device/K252454
Methodology: https://510kreport.com/methodology