Cleared Traditional

K131374 - TEMPUS(TM) CERVICAL PLATE SYSTEM

K131374 is an FDA 510(k) clearance for TEMPUS(TM) CERVICAL PLATE SYSTEM, manufactured by Neurostructures, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K131374 · Neurostructures, LLC · Orthopedic device
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Aug 2013
Decision
102d
Days
Class 2
Risk

K131374 is an FDA 510(k) clearance for the TEMPUS(TM) CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Neurostructures, LLC (Colorado Springs, US). The FDA issued a Cleared decision on August 23, 2013 after a review of 102 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Neurostructures, LLC devices

FDA 510(k) Submission Details - K131374

510(k) Number K131374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2013
Decision Date August 23, 2013
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 493
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K131374.
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · Nuvasive, Inc. · Aug 2013
ASPIRON ACP SYSTEM
K131200 · U&I Corporation · Aug 2013
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
K132012 · Zimmer Spine, Inc. · Aug 2013
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
K130427 · Pioneer Surgical Technology, Inc. · Jun 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · Medtronic Sofamor Danek USA, Inc. · Jun 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013