# K233703: Bone Anchor (NGS-BA-01)

- Pathway: 510(k) (Traditional)
- Applicant: ClearPoint Neuro, Inc.
- Decided: Apr 26, 2024 after 161 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: 4 generations back to K854886 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132611: Microtable System, Fred Haer Company, Inc. (2014) Summary page 5.

## Indications for use
The Bone Anchor is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.

Source page: https://510kreport.com/device/K233703
Methodology: https://510kreport.com/methodology