Cleared Traditional

K242361 - OZARK Cervical Plate System

Also marketed or referenced as:
PYRENEES® Cervical Plate System EVEREST® Spinal System MESA® Spinal System MESA® Small Stature Spinal System CASPIAN® Spinal System DENALI® Spinal System DENALI® MI Spinal System YUKON OCT Spinal System Xia® 3 Spinal System K2M Patient Specific CASCADIA™ Interbody System CAYMAN® Plate System CAYMAN® Plate System-MI

K242361 is the FDA 510(k) clearance for OZARK Cervical Plate System by Stryker Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K242361 · Stryker Spine · Orthopedic device
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Nov 2024
Decision
90d
Days
Class 2
Risk

K242361 is an FDA 510(k) clearance for the OZARK Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on November 7, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Spine devices

Submission Details

510(k) Number K242361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2024
Decision Date November 07, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K242361.
Skyway Anterior Cervical Plate System
K250486 · Kyocera Medical Technologies Inc. (KMTI) · Apr 2025
Elegance® Anterior Cervical plate
K243904 · Clariance · Jan 2025
Cervical Plating System
K243369 · Life Spine, Inc. · Dec 2024
Skyway Anterior Cervical Plate System
K243015 · Kyocera Medical Technologies, Inc. · Nov 2024
FlexWing Anterior Cervical Plate System
K231251 · Jeil Medical Corporation · Jul 2024
Wolff's Law Anterior Cervical Plate System
K240592 · Spinal Simplicity, LLC · May 2024