# K241482: Kinos Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: Jul 22, 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 K920802 (1992). 10 ancestors in all.
2 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)
- K232595: Kinos Axiom Total Ankle System, Restor3D (2023) Summary page 5.

## Most influential descendants
- 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 r3 Tibial Implants of the Kinos Total Ankle System are indicated for revision total ankle arthroplasty. The Kinos Total Ankle System is intended for cement use only.

Source page: https://510kreport.com/device/K241482
Methodology: https://510kreport.com/methodology