# K991081: Frameless Neuromate

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Surgical Systems, Inc.
- Decided: Jun 25, 1999 after 86 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: 2 generations back to K811452 (1981). 3 ancestors in all.
180 later devices descend from it; 6 cite it directly.
5 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963256: Neuromate Stereotactic System, Integrated Surgical Systems, S.A. (1997) Summary page 1.

## Most influential descendants
- 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
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Indications for use
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

Source page: https://510kreport.com/device/K991081
Methodology: https://510kreport.com/methodology