# K191701: Arcus Head Fixation Frame

- Pathway: 510(k) (Traditional)
- Applicant: Mri Interventions, Inc.
- Decided: Nov 15, 2019 after 143 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- 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 K012495 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091439: Head Fixation Arc and Table Base, Surgivision, Inc. (2009) Summary page 4.

## Indications for use
The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient’s head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

Source page: https://510kreport.com/device/K191701
Methodology: https://510kreport.com/methodology