Cleared Traditional

K143399 - Stryker Footed Attachments and Cutting ...

K143399 is the FDA 510(k) clearance for Stryker Footed Attachments and Cutting ... by Stryker Corp.. It is a Class 2 Neurology device (product code HBE) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K143399 · Stryker Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
161d
Days
Class 2
Risk

K143399 is an FDA 510(k) clearance for the Stryker Footed Attachments and Cutting Accessories. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on May 8, 2015 after a review of 161 days - an extended review cycle.

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 Corp. devices

Submission Details

510(k) Number K143399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2014
Decision Date May 08, 2015
Days to Decision 161 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
13d slower than avg
Panel avg: 148d · This submission: 161d
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 K143399.
ELAN 4 Tools
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POWEREASE System
K182436 · Medtronic Sofamor Danek USA, Inc. · Oct 2018
Stryker MIS Attachments and Cutting Accessories
K143540 · Stryker Corporation · May 2015
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K143320 · Stryker Corp. · Apr 2015
POWEREASE SYSTEM
K123270 · Medtronic Sofamor Danek USA, Inc. · Jan 2013