# K112210: Fraxion

- Pathway: 510(k) (Traditional)
- Applicant: Medical Intelligence Medizintechnik GmbH
- Decided: Nov 22, 2011 after 113 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924849 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051746: Elekta Esarte Frame System, Elekta Instrument AB (2005) Summary page 1.
- K092083: Extend Frame System, Model 1009633, Elekta Instrument AB (2009) Summary page 1.
- K030439: Headfix, Medical Intelligence Medizintechnik GmbH (2003) Summary page 1.

## Most influential descendants
- K132908: Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit (2014), 0 descendants of its own

## Indications for use
FraxionTM, is intended to be used for irmp bilisation, positioning and re-positioning during Stereotactic Radiotherapy (SRT) in all Paris of the brain and head in a Linear Accelerator environment. Further FraxionTM is used to immobilise and position the head during image acquisition to support treatment planning. Under certain circumstances (e.g. when the patient will not tolerate an invasive frame) FraxionTM may also be used for Sfereoteclic Radiosurgery (SRS) in a Linear Accelerator environment.

Source page: https://510kreport.com/device/K112210
Methodology: https://510kreport.com/methodology