# K193432: Vantage PSI System

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems
- Decided: Nov 9, 2020 after 335 days
- Product code: OYK (Ankle Arthroplasty Implantation System)
- 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.
6 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170968: PROPHECY INVISION Pre-operative Navigation System, Wrightmedicaltechnologyinc (2017) Summary page 4.

## Most influential descendants
- K241326: Cadence Ankle PSI System (2024), 1 descendant of its own
- K241148: Salto Talaris Ankle PSI System (2024), 1 descendant of its own
- K243173: Salto Talaris Ankle PSI System (2024), 0 descendants of its own
- K243174: Cadence Ankle PSI System (2024), 0 descendants of its own
- K231585: Vantage PSI System (2023), 0 descendants of its own

## Indications for use
The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech’s Vantage Total Ankle System and its cleared indications for use.

Source page: https://510kreport.com/device/K193432
Methodology: https://510kreport.com/methodology