# K141950: HFD100 Rocker Arm Accessory

- Pathway: 510(k) (Special)
- Applicant: Imris, Inc.
- Decided: Sep 4, 2014 after 48 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: 11 generations back to K944964 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103493: Head Fiation Device (HFD 100), Imris, Inc. (2011) Summary page 5.

## Indications for use
The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

Source page: https://510kreport.com/device/K141950
Methodology: https://510kreport.com/methodology