# K170442: Cranial Drill Bits and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corporation
- Decided: Sep 7, 2017 after 205 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961113 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062842: Twist Drill, Walter Lorenz Surgical, Inc. (2006) Summary page 4.
- K122456: Mrii Crainial Drill, Mri Interventions, Inc. (2013) Summary page 4.
- K160129: MRII Cranial Drill and Accessories, Mri Interventions, Inc. (2016) Summary page 4.

## Recalls of this device
- Aug 27, 2019 · Class II · Z-2544-2019: The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
- May 2, 2018 · Class II · Z-2539-2018: The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

## Indications for use
The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.

Source page: https://510kreport.com/device/K170442
Methodology: https://510kreport.com/methodology