Cleared Traditional

K171538 - Cure Lumbar Plate System

K171538 is an FDA 510(k) clearance for Cure Lumbar Plate System, manufactured by Meditech Spine, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K171538 · Meditech Spine, LLC · Orthopedic device
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Jun 2017
Decision
21d
Days
Class 2
Risk

K171538 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 June 16, 2017 after a review of 21 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 Meditech Spine, LLC devices

FDA 510(k) Submission Details - K171538

510(k) Number K171538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2017
Decision Date June 16, 2017
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 480
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K171538.
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
K171439 · Medos International SARL · Jul 2017
Spider Cervical Plating System
K170224 · X-Spine Systems, Inc. · Jul 2017
Terrace™ Anterior Cervical Plate System
K163104 · Corelink, LLC · Jun 2017
Butrex Lumbar Buttress Plating System
K170530 · X-Spine Systems, Inc. · Mar 2017
LOSPA IS ACP System
K161641 · Corentec Co., Ltd. · Jan 2017
CETRA Anterior Cervical Plate System
K162638 · Orthofix, Inc. · Dec 2016