Cleared Special

Cure™ Lumbar Plate System (K201136) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201136 · Meditech Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
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May 2020
Decision
14d
Days
Class 2
Risk

K201136 is an FDA 510(k) clearance for the Cure™ Lumbar Plate 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 May 12, 2020 after a review of 14 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

Submission Details

510(k) Number K201136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2020
Decision Date May 12, 2020
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K201136.
NuVasive Thoracolumbar Plates
K200956 · Nu Vasive, Incorporated · May 2020
Insignia™ Anterior Cervical Plate System
K200995 · Alphatec Spine, Inc. · May 2020
NuVasive® ACP System
K201078 · Nu Vasive, Incorporated · May 2020
Balteum™ Lumbar Plate System
K200846 · Huvexel Co. , Ltd. · May 2020
Biolign® Roto-Loc Cervical Plate System
K200523 · Elite Surgical Supplies (Pty), Ltd. · Apr 2020
Origin™ Anterior Cervical Plate System
K193494 · Orthopaedic & Spine Development · Apr 2020