Cleared Traditional

K190172 - Stryker Elite Attachments

K190172 is the FDA 510(k) clearance for Stryker Elite Attachments by Stryker. It is a Class 2 Neurology device (product code HBE) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K190172 · Stryker · Neurology device
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Jun 2019
Decision
133d
Days
Class 2
Risk

K190172 is an FDA 510(k) clearance for the Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Stryker (Kalamazoo, US). The FDA issued a Cleared decision on June 14, 2019 after a review of 133 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.

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Submission Details

510(k) Number K190172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2019
Decision Date June 14, 2019
Days to Decision 133 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
15d faster than avg
Panel avg: 148d · This submission: 133d
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 Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 40
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K190172.
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