# K080355: Leksell Stereotactic System with Reusable Fixation Screws

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: May 1, 2009 after 445 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 K031999 (2003). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031999: Elekta Leksell Stereotactic System with MR Post Kit, Elekta Instrument AB (2003) Summary page 1.

## Most influential descendants
- K171123: Leksell Vantage Stereotactic System (2017), 4 descendants of its own
- K190887: Leksell Vantage Stereotactic System (2019), 3 descendants of its own
- K210700: NaviNetics D1 Stereotactic System (2021), 1 descendant of its own
- K261932: Leksell® Vantage Stereotactic System (2026), 0 descendants of its own
- K231392: NaviNetics Reusable Stereotactic System (NN1000) (2023), 0 descendants of its own

## Indications for use
The Leksell Stereotactic System® with Reusable Fixation Screws 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/K080355
Methodology: https://510kreport.com/methodology