# K992916: Brainlab Stereotactic Arc

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab
- Decided: Jan 11, 2000 after 134 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The BrainLAB Stereotactic Arc system is an isocentric/target centered stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications in x,y,z directions and in azimuthal and declination angles requiring coordinate-accurate imaging-guided target localization and instrument guidance.

Source page: https://510kreport.com/device/K992916
Methodology: https://510kreport.com/methodology