# K221116: XACT ACE Robotic System

- Pathway: 510(k) (Special)
- Applicant: Xact Robotics, Ltd.
- Decided: May 13, 2022 after 28 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001284 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201586: XACT Robotic System, Xact Robotics, Ltd. (2020) Summary page 4.

## Indications for use
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.

Source page: https://510kreport.com/device/K221116
Methodology: https://510kreport.com/methodology