Cleared Traditional

K171112 - Trifore(tm) Cervical Plating System

K171112 is an FDA 510(k) clearance for Trifore(tm) Cervical Plating System, manufactured by Neurostructures, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K171112

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Empirical Testing Corp
Kenneth C. Maxwell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 550
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K171112.
Spider Cervical Plating System
K170224 · X-Spine Systems, Inc. · Jul 2017
Terrace™ Anterior Cervical Plate System
K163104 · Corelink, LLC · Jun 2017
Cure™ Lumbar Plate System
K171538 · Meditech Spine, LLC · Jun 2017
Ocata Anterior Cervical System
K170342 · Kalitec Direct, LLC · May 2017
Butrex Lumbar Buttress Plating System
K170530 · X-Spine Systems, Inc. · Mar 2017
Altus Spine Cervical Plate System
K163061 · Altus Partners, LLC · Feb 2017