# K051746: Elekta Esarte Frame System

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Jul 25, 2005 after 26 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031980 (2003). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031980: Modification to Leksell Stereotactic System, Elekta Instrument AB (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

## Indications for use
The Elekta EsarteTM Frame System is part of Leksell Stereotactic System®, which is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

Source page: https://510kreport.com/device/K051746
Methodology: https://510kreport.com/methodology