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

K242361 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K242361

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.

KWQ Device Classification - Class 2, Special Controls

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 580
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