Cleared Traditional

K171112 - Trifore(tm) Cervical Plating System

K171112 is the FDA 510(k) clearance for Trifore(tm) Cervical Plating System by Neurostructures, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K171112 · Neurostructures, Inc. · Orthopedic device
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Jun 2017
Decision
55d
Days
Class 2
Risk

K171112 is an FDA 510(k) clearance for the Trifore(tm) Cervical Plating System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Neurostructures, Inc. (Irvine, US). The FDA issued a Cleared decision on June 8, 2017 after a review of 55 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 Neurostructures, Inc. devices

Submission Details

510(k) Number K171112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2017
Decision Date June 08, 2017
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 374
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K171112.
Ozark(tm) Cervical Plate System
K172104 · K2m, Inc. · Aug 2017
NOOSA Anterior Lumbar Plate System
K163625 · Signature Orthopaedics Pty, Ltd. · Aug 2017
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
CETRA Anterior Cervical Plate System
K162638 · Orthofix, Inc. · Dec 2016
Pyrenees Cervical Plate System
K162664 · K2m, Inc. · Oct 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016