Cleared Traditional

Cyclops™ Anterior Cervical Plate System (K191786) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191786 · Degen Medical, Inc. · Orthopedic device
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Aug 2019
Decision
58d
Days
Class 2
Risk

K191786 is an FDA 510(k) clearance for the Cyclops™ Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Degen Medical, Inc. (Florence, US). The FDA issued a Cleared decision on August 30, 2019 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Degen Medical, Inc. devices

Submission Details

510(k) Number K191786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date August 30, 2019
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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

Secure BioMed Evaluations
Linda Braddon

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 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K191786.
RESONATE Anterior Cervical Plate System
K192314 · Globus Medical, Inc. · Oct 2019
FORTICO Anterior Cervical Fixation System
K191584 · Camber Spine Technologies, LLC · Oct 2019
NuVasive® ACP System
K191500 · Nu Vasive, Incorporated · Sep 2019
Binary® Anterior Cervical Plate System
K192076 · Genesys Spine · Aug 2019
Lateral Plate System
K190016 · Corelink, LLC · Jun 2019
Cervical Plate
K190565 · Eisertech, LLC · May 2019