# K233141: SmartFrame OR

- 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 K012366 (2001). 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)
- K012366: Navigus II Trajectory Guide, Image-Guided Neurologics, Inc. (2001) Summary page 5.

## Indications for use
The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction.

Source page: https://510kreport.com/device/K233141
Methodology: https://510kreport.com/methodology