# K132755: Neuromate Frameless Gen II

- Pathway: 510(k) (Traditional)
- Applicant: Renishaw Mayfield Sarl
- Decided: Apr 29, 2014 after 238 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: 3 generations back to K811452 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991081: Frameless Neuromate, Integrated Surgical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K180206: neuromate Gen III (2018), 0 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/K132755
Methodology: https://510kreport.com/methodology