# K092083: Extend Frame System, Model 1009633

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Sep 22, 2009 after 75 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924849 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063512: Leksell Gamma Knife Perfexion, Elekta Instrument AB (2007) Summary page 1.
- K030439: Headfix, Medical Intelligence Medizintechnik GmbH (2003) Summary page 1.

## Most influential descendants
- K112210: Fraxion (2011), 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

## Recalls of this device
- Sep 17, 2010 · Not classified · Z-0163-2011: The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy.

## Indications for use
Leksell Gamma Knife Perfexion Tm with ExtendTM Frame System is a teletherapy device intended for stereotactic irradiation of head structures.

Source page: https://510kreport.com/device/K092083
Methodology: https://510kreport.com/methodology