Cleared Traditional

K210377 - Stryker iBur hubs and cutting accessories (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210377 · Stryker Corporation · Neurology device

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Jun 2021

Decision

141d

Days

Class 2

Risk

K210377 is an FDA 510(k) clearance for the Stryker iBur hubs and cutting accessories. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on June 30, 2021 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corporation devices

Submission Details

510(k) Number	K210377 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 2021
Decision Date	June 30, 2021
Days to Decision	141 days
Submission Type	Traditional
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

7d faster than avg

Panel avg: 148d · This submission: 141d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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 Consultant

Stryker

Alison Garrad

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.