Cleared Traditional

K173867 - Axis Anterior Cervical Plate System

K173867 is the FDA 510(k) clearance for Axis Anterior Cervical Plate System by Axis Orthopaedics. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K173867 · Axis Orthopaedics · Orthopedic device
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Apr 2018
Decision
106d
Days
Class 2
Risk

K173867 is an FDA 510(k) clearance for the Axis Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Axis Orthopaedics (Soldotna, US). The FDA issued a Cleared decision on April 5, 2018 after a review of 106 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 Axis Orthopaedics devices

Submission Details

510(k) Number K173867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2017
Decision Date April 05, 2018
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 Consultant

Coorstek Medical
Steve Brown

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 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K173867.
Life Spine Lumbar Fixation System (SENTRY)
K180166 · Life Spine, Inc. · Jun 2018
Cure™ Lumbar Plate System
K180090 · Meditech Spine, LLC · Apr 2018
Mediant Anterior Cervical Plating System
K173935 · Intelligent Implant Systems, LLC · Apr 2018
Genesys Spine Binary Lumbar Plate System
K173885 · Genesys Spine · Apr 2018
Zavation Buttress Plate System
K180537 · Zavation Medical Products, LLC · Mar 2018
TRYPTIK2 C-Plate Anterior Cervical Plate System
K171797 · Spineart · Feb 2018