# K123954: Infinity Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 1, 2013 after 101 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). 6 ancestors in all.
52 later devices descend from it; 11 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051023: Topez Total Ankle Replacement, Topez Orthopedics, Inc. (2005) Summary page 1.
- K053569: Agility LP Total Ankle Prosthesis, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K100886: Inbone II Total Ankle Replacement, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K103374: Inbone Total Ankle System Model 200347902, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Most influential descendants
- K140749: Infinity Total Ankle System (2014), 48 descendants of its own
- K133585: Inbone Total Ankle (2014), 34 descendants of its own
- K153008: INVISION Total Ankle Revision System (2016), 29 descendants of its own
- K142117: Invision Total Ankle Revision System (2015), 29 descendants of its own
- K131283: Prophecy Infinity Preoperative Navigation Alignment Guides (2013), 18 descendants of its own

## Recalls of this device
- Mar 6, 2024 · Class II · Z-1477-2024: Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the fi
- Jun 13, 2023 · Class II · Z-2105-2023: The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

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

Source page: https://510kreport.com/device/K123954
Methodology: https://510kreport.com/methodology