# K193067: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jun 8, 2020 after 217 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: 9 generations back to K920802 (1992). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140749: Infinity Total Ankle System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K133585: Inbone Total Ankle, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K100886: Inbone II Total Ankle Replacement, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K142117: Invision Total Ankle Revision System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K180730: INVISION Total Ankle Revision System, Wrightmedicaltechnologyinc (2018) Summary page 4.

## Most influential descendants
- K250037: Incompass Total Ankle System (2025), 1 descendant of its own
- K253159: Prophecy Incompass Surgical Planning System (2026), 0 descendants of its own

## Indications for use
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post‐traumatic, or degenerative arthritis. The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are 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/K193067
Methodology: https://510kreport.com/methodology