# K963256: Neuromate Stereotactic System

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Surgical Systems, S.A.
- Decided: May 9, 1997 after 263 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: 1 generation back to K811452 (1981). 2 ancestors in all.
182 later devices descend from it; 3 cite it directly.
5 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811452: Brown-Roberts-Wells Stereotaxic Sytem, Trent Wells, Inc. (1981) Summary page 1.
- K871046: Compass Stereotactic Positioning System, Stereotactic Medical Systems, Inc. (1987). Our OCR of the scanned summary read K871048, FDA’s number for Micro Mammo I Mammography Unit (Amerasia Import-Export, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “COMPASS Stereotactic System”. Summary page 5.

## Most influential descendants
- K991081: Frameless Neuromate (1999), 180 descendants of its own
- K060556: Brigit Surgical Device (2006), 128 descendants of its own
- K092239: Rosa Surgical Device, Model Rosa 1.1 (2009), 127 descendants of its own
- K101791: Rosa Surgical Device (2010), 126 descendants of its own
- K151511: ROSA Spine (2016), 109 descendants of its own

## Indications for use
The NeuroMate Stereotactic System, the BRW Stereotactic System and the Compass Stereotactic Systems are intended for the stereotactic spatial positioning and orientation of an instrument or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

Source page: https://510kreport.com/device/K963256
Methodology: https://510kreport.com/methodology