# K031980: Modification to Leksell Stereotactic System

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Jul 25, 2003 after 29 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
No predicates in its family tree.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051746: Elekta Esarte Frame System (2005), 2 descendants of its own
- 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 Leksell Stereotactic System with disposable biopsy needle kit is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

Source page: https://510kreport.com/device/K031980
Methodology: https://510kreport.com/methodology