# K151459: Integra Total Ankle Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics
- Decided: Aug 31, 2015 after 91 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K920802 (1992). 4 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100886: Inbone II Total Ankle Replacement, Wrightmedicaltechnologyinc (2010) Summary page 7.

## Most influential descendants
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), 8 descendants of its own
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 descendants of its own
- K171004: Hintermann Series H2 Total Ankle System (2017), 2 descendants of its own
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own
- K202019: Maven Patient-Specific Instrumentation (2021), 1 descendant of its own

## Recalls of this device
- Jan 20, 2017 · Class II · Z-1192-2017: Posterior tibial fractures have been reported.
- Apr 29, 2016 · Class II · Z-2086-2016: As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incor

## 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) The 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.

Source page: https://510kreport.com/device/K151459
Methodology: https://510kreport.com/methodology