# K003776: Microtargeting Drive System

- Pathway: 510(k) (Traditional)
- Applicant: FHC, Inc.
- Decided: Feb 23, 2001 after 78 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092192: Waypoint Stereotactic System (2010), 4 descendants of its own
- K132611: Microtable System (2014), 1 descendant of its own
- K092562: Microtargeting Star Drive System, Components (2009), 1 descendant of its own
- K011775: Micro Targeting Drive System (2001), 1 descendant of its own
- K233703: Bone Anchor (NGS-BA-01) (2024), 0 descendants of its own

## Recalls of this device
- Mar 30, 2010 · Not classified · Z-0313-2011: Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
- 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-0311-2011: Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
- Mar 14, 2005 · Not classified · Z-0895-05: Potential for non-sterile pin to contaminate sterile field

Source page: https://510kreport.com/device/K003776
Methodology: https://510kreport.com/methodology