# K223552: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 19, 2023 after 145 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: 6 generations back to K983410 (1999). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211544: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization, Brainlab AG (2021) Summary page 4.
- K092192: Waypoint Stereotactic System, FHC, Inc. (2010) Summary page 4.

## Indications for use
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/K223552
Methodology: https://510kreport.com/methodology