# K231141: STarFix Designer Software C0265

- Pathway: 510(k) (Traditional)
- Applicant: FHC, Inc.
- Decided: Sep 8, 2023 after 140 days
- Product code: QRI (Surgical Planning Software For Neurological Stereotaxic Instruments)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854886 (1986). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092192: Waypoint Stereotactic System, FHC, Inc. (2010) Summary page 4.

## Indications for use
The STarFix Designer Software is part of the WayPoint Stereotactic System. The WayPoint Stereotactic System is intended to be used with commercially available stereotactic system for neurological procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Source page: https://510kreport.com/device/K231141
Methodology: https://510kreport.com/methodology