# K233144: ClearPoint Bone Screw Fiducials

- Pathway: 510(k) (Traditional)
- Applicant: ClearPoint Neuro, Inc.
- Decided: Jan 12, 2024 after 107 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- 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: 1 generation back to K033619 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033619: Navigus Unibody Fiducial Marker System, Model FM-4000, Image-Guided Neurologics, Inc. (2004) Summary page 5.

## Indications for use
The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

Source page: https://510kreport.com/device/K233144
Methodology: https://510kreport.com/methodology