# K030439: Headfix

- Pathway: 510(k) (Traditional)
- Applicant: Medical Intelligence Medizintechnik GmbH
- Decided: May 8, 2003 after 86 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Radionics Gill-Thomas-Cosman (GTC) Relocatable Head Holder: named in the summary without a submission number
- (no number) Orfit Industries’ Raycast Immobilization Systems Hardware and Thermoplastic Materials: named in the summary without a submission number
- (no number) BrainLAB’s Brain Mask System: named in the summary without a submission number

## Most influential descendants
- K092083: Extend Frame System, Model 1009633 (2009), 2 descendants of its own
- K112210: Fraxion (2011), 1 descendant of its own
- K081935: Stereotactic Head and Neck Localizer, Model 50-100 (2008), 1 descendant of its own
- K132908: Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit (2014), 0 descendants of its own
- K103616: Pinpoint Stereotactic Head and Neck Localizer (2011), 0 descendants of its own

## Recalls of this device
- Oct 14, 2010 · Not classified · Z-0538-2011: The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate.

## Indications for use
This product is intended for use by radiologists and surgeons for: Positioning and repositioning of the patient’s head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets

Source page: https://510kreport.com/device/K030439
Methodology: https://510kreport.com/methodology