Cleared Special

K210286 - Cure 2.0 Anterior Cervical Plate (ACP) ...

K210286 is an FDA 510(k) clearance for Cure 2.0 Anterior Cervical Plate (ACP) ..., manufactured by Meditech Spine, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 44-day FDA review.

K210286 · Meditech Spine, LLC · Orthopedic device
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Mar 2021
Decision
44d
Days
Class 2
Risk

K210286 is an FDA 510(k) clearance for the Cure 2.0 Anterior Cervical Plate (ACP) System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Meditech Spine, LLC (Atlanta, US). The FDA issued a Cleared decision on March 18, 2021 after a review of 44 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Meditech Spine, LLC devices

FDA 510(k) Submission Details - K210286

510(k) Number K210286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2021
Decision Date March 18, 2021
Days to Decision 44 days
Submission Type Special
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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

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 K210286.
CervAlign® Anterior Cervical Plate System
K211408 · Pioneer Surgical Technology, Inc. · Jun 2021
PANAMA™ Anterior Cervical Plate (ACP) System
K210182 · Flospine · Apr 2021
APOLLO Anterior Cervical Plate (ACP) System
K210325 · Aurora Spine, Inc. · Mar 2021
Lumbar Spine Truss System Plating Solution (LSTS-PS)
K203065 · 4Web, Inc. · Mar 2021
Prase-AP Anterior Cervical Plate System
K202878 · Gbs Commonwealth Co., Ltd. · Jan 2021
NuVasive ACP System
K203253 · Nu Vasive, Incorporated · Dec 2020