Cleared Traditional

K120515 - TEMPUS CERVICAL PLATE SYSTEM

K120515 is an FDA 510(k) clearance for TEMPUS 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 92-day FDA review.

K120515 · Neurostructures, LLC · Orthopedic device
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May 2012
Decision
92d
Days
Class 2
Risk

K120515 is an FDA 510(k) clearance for the TEMPUS 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 May 23, 2012 after a review of 92 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 - K120515

510(k) Number K120515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2012
Decision Date May 23, 2012
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 K120515.
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
K121837 · Nuvasive, Inc. · Jul 2012
SPINE FRONTIER INDUS ACP SYSTEM
K121060 · Spinefrontier, Inc. · Jul 2012
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · Globus Medical, Inc. · Jun 2012
PIONEER LATERAL PLATE SYSTEM
K120724 · Pioneer Surgical Technology, Inc. · May 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · Globus Medical, Inc. · Apr 2012
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K112206 · Seaspine, Inc. · Jan 2012