Cleared Traditional

K221572 - VyPlate Anterior Cervical Plate System

K221572 is the FDA 510(k) clearance for VyPlate Anterior Cervical Plate System by Vy Spine, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K221572 · Vy Spine, LLC · Orthopedic device
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Jul 2022
Decision
55d
Days
Class 2
Risk

K221572 is an FDA 510(k) clearance for the VyPlate Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on July 26, 2022 after a review of 55 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 Vy Spine, LLC devices

Submission Details

510(k) Number K221572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2022
Decision Date July 26, 2022
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 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 K221572.
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate
K221728 · Stryker Corporation · Oct 2022
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
Venus Cervical Plate System
K211718 · Artfx Medical, LLC · Jun 2022
Cervical Spine Truss System Plating Solution (CSTS-PS)
K212527 · 4Web Medical, Inc. · May 2022
Aggeris™-C
K220182 · Clariance · Mar 2022