# K061749: Eclipse Total Ankle Implant

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Nov 22, 2006 after 154 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: 2 generations back to K920802 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020541: Agility Ankle Revision Prosthesis, Depuy, Inc. (2002) Summary page 1.

## Indications for use
The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients affected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement.

Source page: https://510kreport.com/device/K061749
Methodology: https://510kreport.com/methodology