# K091439: Head Fixation Arc and Table Base

- Pathway: 510(k) (Traditional)
- Applicant: Surgivision, Inc.
- Decided: Aug 25, 2009 after 103 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: 2 generations back to K012495 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071179: Noras or Head Holder, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K874298: Malcolm-Rand Microneurosurgical Cranio-Xray Frame, Engineered Orthopedic Technologies, Inc. (1988) Summary page 1.

## Most influential descendants
- K191701: Arcus Head Fixation Frame (2019), 0 descendants of its own

## Indications for use
The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

Source page: https://510kreport.com/device/K091439
Methodology: https://510kreport.com/methodology