Cleared Traditional

K211718 - Venus Cervical Plate System

K211718 is an FDA 510(k) clearance for Venus Cervical Plate System, manufactured by Artfx Medical, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K211718 · Artfx Medical, LLC · Orthopedic device
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Jun 2022
Decision
389d
Days
Class 2
Risk

K211718 is an FDA 510(k) clearance for the Venus Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Artfx Medical, LLC (Jacksonville, US). The FDA issued a Cleared decision on June 28, 2022 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Artfx Medical, LLC devices

FDA 510(k) Submission Details - K211718

510(k) Number K211718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2021
Decision Date June 28, 2022
Days to Decision 389 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 122d · This submission: 389d
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 Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 479
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K211718.
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
K222572 · Dio Medical Corporation · Oct 2022
CYGNUS™ MoRe Anterior Cervical Plate System
K220441 · MiRus, LLC · Sep 2022
VyPlate Anterior Cervical Plate System
K221572 · Vy Spine, LLC · Jul 2022
Cervical Spine Truss System Plating Solution (CSTS-PS)
K212527 · 4Web Medical, Inc. · May 2022
Aggeris™-C
K220182 · Clariance · Mar 2022
BALTEUM - ONE™ Lumbar Plate System
K213820 · Huvexel Co. , Ltd. · Mar 2022