Cleared Traditional

K172585 - Liberty Anterior Cervical Plate

K172585 is an FDA 510(k) clearance for Liberty Anterior Cervical Plate, manufactured by Valorus Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K172585 · Valorus Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
56d
Days
Class 2
Risk

K172585 is an FDA 510(k) clearance for the Liberty Anterior Cervical Plate. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Valorus Spine (Danville, US). The FDA issued a Cleared decision on October 23, 2017 after a review of 56 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 Valorus Spine devices

FDA 510(k) Submission Details - K172585

510(k) Number K172585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2017
Decision Date October 23, 2017
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 Consultant

Watershed Idea Foundry
Nick Cordaro

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 595
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K172585.
Anterior Cervical Plate System
K173375 · Evolution Spine, LLC · Dec 2017
Boundary Anterior Lumbar Buttress Plate
K173091 · Nvision Biomedical Technologies, LLC · Dec 2017
Fortis and Hana Anterior Cervical Plate System
K173099 · Huvexel Co. , Ltd. · Nov 2017
Shanghai Sanyou CARMEN Cervical Fusion System
K163366 · Shanghai Sanyou Medical Co, Ltd. · Oct 2017
Matira™ Anterior Cervical System
K172086 · Kalitec Direct, LLC · Sep 2017
2 Hole Lateral Plating System
K172131 · Life Spine, Inc. · Aug 2017