# K092562: Microtargeting Star Drive System, Components

- Pathway: 510(k) (Special)
- Applicant: FHC, Inc.
- Decided: Sep 18, 2009 after 29 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003776 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K121950: Microtargeting XL Star Drive System (2012), 0 descendants of its own

## Recalls of this device
- May 10, 2018 · Class II · Z-2357-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- May 10, 2018 · Class II · Z-2349-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- May 10, 2018 · Class II · Z-2351-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- May 10, 2018 · Class II · Z-2358-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- May 10, 2018 · Class II · Z-2352-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- May 10, 2018 · Class II · Z-2354-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- May 10, 2018 · Class II · Z-2350-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- Mar 30, 2010 · Not classified · Z-0314-2011: Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
- Mar 30, 2010 · Not classified · Z-0312-2011: Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.

## Indications for use
The FHC microTargetingTM STar DriveTM System is intended to be used with commercially available positioning 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/K092562
Methodology: https://510kreport.com/methodology