# K180730: INVISION Total Ankle Revision System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 11, 2018 after 113 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: 8 generations back to K920802 (1992). 14 ancestors in all.
3 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)
- K171067: INVISION Total Ankle Revision System, Wrightmedicaltechnologyinc (2017) Summary page 4.
- K153008: INVISION Total Ankle Revision System, Wrightmedicaltechnologyinc (2016) Summary page 4.
- K103374: Inbone Total Ankle System Model 200347902, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K133585: Inbone Total Ankle, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Most influential descendants
- K193067: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System (2020), 2 descendants of its own
- 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 INVISION™ Total Ankle Revision System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INVISION™ Total Ankle Revision 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/K180730
Methodology: https://510kreport.com/methodology