# K163666: neuro  inspire

- Pathway: 510(k) (Traditional)
- Applicant: Rensihaw Plc
- Decided: Sep 15, 2017 after 262 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.
No later device cites it as a predicate yet.
0 of 9 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.

## Indications for use
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire defines a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire. neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer). No other components of the Leksell Stereotactic System should be used. No other stereotactic system should be used. The user should consult Section 1.7 Accuracy of these Instructions for Use to assess if the accuracy of neuroinspire is suitable for their needs.

Source page: https://510kreport.com/device/K163666
Methodology: https://510kreport.com/methodology