Cleared Special

Skyway Anterior Cervical Plate System (K250486) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250486 · Kyocera Medical Technologies Inc. (KMTI) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
50d
Days
Class 2
Risk

K250486 is an FDA 510(k) clearance for the Skyway Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Kyocera Medical Technologies Inc. (KMTI) (Redlands, US). The FDA issued a Cleared decision on April 10, 2025 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kyocera Medical Technologies Inc. (KMTI) devices

Submission Details

510(k) Number K250486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2025
Decision Date April 10, 2025
Days to Decision 50 days
Submission Type Special
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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Empirical Technologies
Nathan Wright

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.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 243
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K250486.
Resolve Anterior Cervical Plate System
K251436 · Pioneer Surgical Technology, Inc. · Jul 2025
Frida™ Anterior Cervical Plate System
K250446 · Spineup, Inc. · May 2025
X-PAC® N-GAGE™ Lumbar Plate System
K250602 · Expanding Innovations, Inc. · May 2025
Elegance® Anterior Cervical plate
K243904 · Clariance · Jan 2025
Cervical Plating System
K243369 · Life Spine, Inc. · Dec 2024
OZARK Cervical Plate System
K242361 · Stryker Spine · Nov 2024