# K231585: Vantage PSI System

- Pathway: 510(k) (Special)
- Applicant: 3D Systems, Inc.
- Decided: Jun 30, 2023 after 30 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: 10 generations back to K920802 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193432: Vantage PSI System, 3D Systems (2020) Summary page 4.

## 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 intra-operatively, 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/K231585
Methodology: https://510kreport.com/methodology