Cleared Traditional

K061353 - TRINICA ANTERIOR LUMBAR PLATE SYSTEM

K061353 is the FDA 510(k) clearance for TRINICA ANTERIOR LUMBAR PLATE SYSTEM by Zimmer Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K061353 · Zimmer Spine, Inc. · Orthopedic device
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Aug 2006
Decision
107d
Days
Class 2
Risk

K061353 is an FDA 510(k) clearance for the TRINICA ANTERIOR LUMBAR PLATE SYSTEM. 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 30, 2006 after a review of 107 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 Zimmer Spine, Inc. devices

Submission Details

510(k) Number K061353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2006
Decision Date August 30, 2006
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K061353.
KINETIC ANTERIOR CERVICAL PLATE
K062643 · Life Spine · Nov 2006
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · Life Spine · Oct 2006
GATEWAY THORACOLUMBAR PLATE SYSTEM
K062407 · Globus Medical, Inc. · Sep 2006
REFLEX HYBRID ACP SYSTEM
K062310 · Stryker Spine · Aug 2006
LATERAL PLATE SYSTEM
K061789 · Nuvasive, Inc. · Aug 2006
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K061229 · Blackstone Medical, Inc. · Jul 2006