# K241148: Salto Talaris Ankle PSI System

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems, Inc.
- Decided: Aug 30, 2024 after 127 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.
1 later device descends 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)
- K193432: Vantage PSI System, 3D Systems (2020) Summary page 5.

## Most influential descendants
- K243173: Salto Talaris Ankle PSI System (2024), 0 descendants of its own

## Indications for use
The Salto Talaris 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 Salto Talaris PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use.

Source page: https://510kreport.com/device/K241148
Methodology: https://510kreport.com/methodology