# K011775: Micro Targeting Drive System

- Pathway: 510(k) (Traditional)
- Applicant: FHC, Inc.
- Decided: Aug 30, 2001 after 84 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811452 (1981). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003776: Microtargeting Drive System, FHC, Inc. (2001) Summary page 2.
- K990683: Axon MP-1 Micropositioner, Axon Instruments, Inc. (1999) Summary page 3.
- K992721: Cosman Robert Wells Functional Probe Microdrive, Radionics, Inc. (1999). Our OCR of the scanned summary read K292721, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Radionics Cosman Robett Wells Functional Probe Microdrive (CRW-FMD)”.
- K991077: Microelectroencephalography Professional System 5000 (Eeg Pro System 5000), Microrecording Systems Consultants, LLC (1999) Summary page 2.

## Most influential descendants
- K040979: Elekta Microdrive, Model 916716 (2004), 0 descendants of its own

## Recalls of this device
- Oct 4, 2024 · Class I · Z-0312-2025: A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was
- May 10, 2018 · Class II · Z-2346-2018: 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-2355-2018: 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-2348-2018: 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-2356-2018: 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-2347-2018: 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-2345-2018: 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 14, 2005 · Not classified · Z-0895-05: Potential for non-sterile pin to contaminate sterile field

## Indications for use
The FHC ricroTargeting® Drive System is intended-to be used with commetcially available stereotactic systerns for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, DBS™ electrodes of other instruments in the brain or nervous system.

Source page: https://510kreport.com/device/K011775
Methodology: https://510kreport.com/methodology