# K190887: Leksell Vantage Stereotactic System

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Aug 1, 2019 after 119 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K031999 (2003). 3 ancestors in all.
3 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)
- K080355: Leksell Stereotactic System with Reusable Fixation Screws, Elekta Instrument AB (2009) Summary page 4.
- K171123: Leksell Vantage Stereotactic System, Elekta Instrument AB (2017) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Mar 19, 2026 · Class II · Z-2006-2026: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
- Sep 30, 2025 · Class II · Z-0433-2026: Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
- Mar 30, 2020 · Class II · Z-1826-2020: A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

## Indications for use
The Intended Purpose of Leksell® Vantage™ Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Source page: https://510kreport.com/device/K190887
Methodology: https://510kreport.com/methodology