Cleared Traditional

K193494 - Origin Anterior Cervical Plate System

K193494 is the FDA 510(k) clearance for Origin Anterior Cervical Plate System by Orthopaedic & Spine Development. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K193494 · Orthopaedic & Spine Development · Orthopedic device
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Apr 2020
Decision
111d
Days
Class 2
Risk

K193494 is an FDA 510(k) clearance for the Origin™ Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Orthopaedic & Spine Development (Avignon Cedex 9, FR). The FDA issued a Cleared decision on April 6, 2020 after a review of 111 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 Orthopaedic & Spine Development devices

Submission Details

510(k) Number K193494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date April 06, 2020
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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

Phiama, Inc.
Roger N White

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 K193494.
Cure™ Lumbar Plate System
K201136 · Meditech Spine, LLC · May 2020
Balteum™ Lumbar Plate System
K200846 · Huvexel Co. , Ltd. · May 2020
Biolign® Roto-Loc Cervical Plate System
K200523 · Elite Surgical Supplies (Pty), Ltd. · Apr 2020
SEA-LINK Anterior Cervical Plate System
K200224 · Indius Medical Technologies Pvt. , Ltd. · Mar 2020
SpineNet SSP System
K200170 · Spinenet, LLC · Feb 2020
TranS1 AxiaLIF Plus System
K192792 · Trans1 · Nov 2019