# K201507: Cadence Total Ankle System

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Jun 29, 2020 after 24 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: 5 generations back to K920802 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151459: Integra Total Ankle Replacement System, Ascension Orthopedics (2015) Summary page 4.

## Indications for use
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. The Cadence Total Ankle System is indicated for use to treat: - Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis) - Primary arthritis (e.g. degenerative disease) - Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved) Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis. Provided sufficient bone stock is present. Note – In the United States, this device is intended for cemented use only. Note – Outside the United States, this device is intended for cemented or cementless use.

Source page: https://510kreport.com/device/K201507
Methodology: https://510kreport.com/methodology