# K171067: INVISION Total Ankle Revision System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 11, 2017 after 154 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: 7 generations back to K920802 (1992). 13 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142117: Invision Total Ankle Revision System, Wrightmedicaltechnologyinc (2015) Summary page 5.
- K153008: INVISION Total Ankle Revision System, Wrightmedicaltechnologyinc (2016) Summary page 5.
- K141740: Infinity (TM) Total Ankle System; Inbone Total Ankle System, Wrightmedicaltechnologyinc (2015) Summary page 5.

## Most influential descendants
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), 8 descendants of its own
- K180730: INVISION Total Ankle Revision System (2018), 3 descendants of its own
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 descendants of its own
- 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

## 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/K171067
Methodology: https://510kreport.com/methodology