# K211544: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Nov 3, 2021 after 168 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: 5 generations back to K983410 (1999). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101627: IPLAN, Brainlab AG (2011) Summary page 4.

## Most influential descendants
- K223552: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (2023), 0 descendants of its own

## Indications for use
The Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures. Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy. This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy): Catheter placement Depth electrode placement (SEEG procedures) Lead placement and detection (DBS procedures) Probe placement Cranial biopsies

Source page: https://510kreport.com/device/K211544
Methodology: https://510kreport.com/methodology