# K092192: Waypoint Stereotactic System

- Pathway: 510(k) (Traditional)
- Applicant: FHC, Inc.
- Decided: Feb 12, 2010 after 206 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 K854886 (1986). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003776: Microtargeting Drive System, FHC, Inc. (2001) Summary page 1.
- K961120: Marker System for Stereotaxic Navigation, Howmedica Leibinger, Inc. (1996) Summary page 1.
- K080250: Leksell Surgiplan, Model 1006947, Elekta Instrument AB (2008) Summary page 1.
- K972324: Leksell Stereotactic System, Elekta Instrument AB (1998) Summary page 1.

## Most influential descendants
- K132611: Microtable System (2014), 1 descendant of its own
- K233703: Bone Anchor (NGS-BA-01) (2024), 0 descendants of its own
- K231141: STarFix Designer Software C0265 (2023), 0 descendants of its own
- K223552: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (2023), 0 descendants of its own

## Indications for use
The WayPoint™ Stereotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Source page: https://510kreport.com/device/K092192
Methodology: https://510kreport.com/methodology