510(k) · Cleared

Recalled · Class II · 2019

Cranial Drill Bits and Accessories

K170442510(k) TraditionalCleared Sep 7, 2017205-day reviewClass II21 CFR 882.4310Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ad-Tech Medical Instrument Corporation · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on Sep 7, 2017 as substantially equivalent to K062842 (Walter Lorenz Surgical, Inc., 2006) and 2 other predicates after a 205-day review. Its family tree reaches back 4 generations to 1996. It has been recalled 2 times.

Decided: Sep 7, 2017
Review: 205 days
Class: Class II
Product code: HBE
Recalls: 2
Predicates: 3

Its longest line of descent runs back 4 generations to K961113 (1996). 9 ancestors in all, the oldest K832187 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK961113 CNS Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC · 1996 · Recalled
3 generations backK122456 Mrii Crainial DrillMri Interventions, Inc. · 2013
2 generations backK151536 SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 2015
1 generation backK160129 MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016
This deviceK170442 Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K961113	CNS Interchangeable Bit Cranial Drill	Clinical Neuro Systems, LLC	1996	39
−3	K122456	Mrii Crainial Drill	Mri Interventions, Inc.	2013	—
−2	K151536	SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm	Mri Interventions, Inc.	2015	—
−1	K160129	MRII Cranial Drill and Accessories	Mri Interventions, Inc.	2016	—
0 (this device)	K170442	Cranial Drill Bits and Accessories	Ad-Tech Medical Instrument Corporation	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1996	1	0
2002	1	0
2003	1	0
2006	1	0

FIG. 1 — Lineage of K170442, 1996–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HBE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HBE device

#1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.1 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K062842	Twist Drill Summary page 4 …882.4300 Manual cranial drills, burrs, trephines, and their accessories, Product Code: HBG, Class II Predicate Devices: K062842 Twist Drills (Bits), Primary Predicate K122456 MRI Cranial Drill…	Walter Lorenz Surgical, Inc.	2006	1
*	K122456	Mrii Crainial Drill Summary page 4 …accessories, Product Code: HBG, Class II Predicate Devices: K062842 Twist Drills (Bits), Primary Predicate K122456 MRI Cranial Drill K160129 MRII Cranial Drill and Accessories 5.1 Product Description…	Mri Interventions, Inc.	2013	—
*	K160129	MRII Cranial Drill and Accessories Summary page 4 …Predicate Devices: K062842 Twist Drills (Bits), Primary Predicate K122456 MRI Cranial Drill K160129 MRII Cranial Drill and Accessories 5.1 Product Description The device under review is a family of cranial drill bits an…	Mri Interventions, Inc.	2016	—

Also cleared against K062842: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 27, 2019	Class II	Z-2544-2019	Under Investigation by firm	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	Nonconforming Material/Component	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
3 of the 9 ancestors have a recall of any class.
3 other devices also cite its predicate K062842.

How does its category compare?

All HBE devices

HBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HBE

6in 2025

2007high 6 (2021) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBE

30in 2025

2007high 193 (2021) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HBE

1in 2024

2007high 47 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBE

1,924in 2025

2007high 1,924 (2025) · low 14 (2007)2025

MAUDE reports naming product code HBE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	14
2008	2	—	47	14
2009	0	—	7	242
2010	0	—	23	492
2011	2	—	1	1,013
2012	1	—	26	1,146
2013	1	—	4	1,583
2014	2	—	0	559
2015	3	155	0	483
2016	2	—	7	848
2017	2	—	3	848
2018	2	—	0	787
2019	5	133	0	836
2020	0	—	0	1,025
2021	6	193	1	1,047
2022	2	—	0	900
2023	2	—	3	948
2024	0	—	1	1,153
2025	6	30	0	1,924
2026	1	—	19	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170442: Cranial Drill Bits and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170442

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026