Cleared Special

K250374 - iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D) (FDA 510(k) Clearance)

Also includes:
iBur 3.0mm Precision Round, Distal Bend (8431-009-030) iBur 4.0mm Precision Round, Distal Bend (8431-009-040) iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D) iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D) iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D) iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC) iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC) iBur 5.0mm Coarse Diamond R

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250374 · Stryker Instruments · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
29d
Days
Class 2
Risk

K250374 is an FDA 510(k) clearance for the iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D). Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on March 11, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Instruments devices

Submission Details

510(k) Number K250374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2025
Decision Date March 11, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 64
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K250374.
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K251433 · Surgify Medical OY · Jun 2025
Surgify Halo (54.085.SHD.H1)
K250380 · Surgify Medical OY · Mar 2025