# K243174: Cadence Ankle PSI System

- Pathway: 510(k) (Special)
- Applicant: 3D Systems, Inc.
- Decided: Oct 25, 2024 after 25 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: 11 generations back to K920802 (1992). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241326: Cadence Ankle PSI System, 3D Systems, Inc. (2024) Summary page 5.

## Indications for use
The Cadence Ankle 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 Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

Source page: https://510kreport.com/device/K243174
Methodology: https://510kreport.com/methodology