Cleared Traditional

K132012 - TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM

K132012 is an FDA 510(k) clearance for TRINICA ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Zimmer Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K132012 · Zimmer Spine, Inc. · Orthopedic device
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Aug 2013
Decision
59d
Days
Class 2
Risk

K132012 is an FDA 510(k) clearance for the TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICA.... Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Zimmer Spine, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 29, 2013 after a review of 59 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 Zimmer Spine, Inc. devices

FDA 510(k) Submission Details - K132012

510(k) Number K132012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date August 29, 2013
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 602
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K132012.
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
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K131512 · Shanghai Sanyou Medical Co, Ltd. · Aug 2013
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K131520 · Core-Nexus · Jul 2013