# K181557: INFINITY Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 9, 2018 after 57 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: 11 generations back to K911686 (1991). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123954: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K140749: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K172633: INFINITY Total Ankle System, Wrightmedicaltechnologyinc (2018) Summary page 4.
- K141740: Infinity (TM) Total Ankle System; Inbone Total Ankle System, Wrightmedicaltechnologyinc (2015) Summary page 4.

## Indications for use
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

Source page: https://510kreport.com/device/K181557
Methodology: https://510kreport.com/methodology