Cleared Traditional

K061353 - TRINICA ANTERIOR LUMBAR PLATE SYSTEM

K061353 is an FDA 510(k) clearance for TRINICA ANTERIOR LUMBAR 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 107-day FDA review.

K061353 · Zimmer Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K061353

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.

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 K061353.
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · Life Spine · Oct 2006
UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
K062686 · Advanced Spine Technology, Inc. · Oct 2006
GATEWAY THORACOLUMBAR PLATE SYSTEM
K062407 · Globus Medical, Inc. · Sep 2006
REFLEX HYBRID ACP SYSTEM
K062310 · Stryker Spine · Aug 2006
VERTEBRON SCP CERVICAL PLATE SYSTEM
K062110 · Vertebron, Inc. · Aug 2006
LATERAL PLATE SYSTEM
K061789 · Nuvasive, Inc. · Aug 2006