Cleared Traditional

K051531 - TECTONIC CERVICAL PLATE SYSTEM

K051531 is the FDA 510(k) clearance for TECTONIC CERVICAL PLATE SYSTEM by K2m, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K051531 · K2m, LLC · Orthopedic device
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Oct 2005
Decision
130d
Days
Class 2
Risk

K051531 is an FDA 510(k) clearance for the TECTONIC CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by K2m, LLC (Leesburg, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 130 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 K2m, LLC devices

Submission Details

510(k) Number K051531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2005
Decision Date October 17, 2005
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 422
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K051531.
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
K053581 · Nuvasive, Inc. · Feb 2006
AEGIS ANTERIOR LUMBAR PLATE SYSTEM
K052546 · Depuy Spine, Inc. · Feb 2006
PACP SYSTEM
K053053 · Pioneer Surgical Technology · Nov 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005
SYNTHES VECTRA-T SYSTEM
K051665 · Synthes Spine · Sep 2005
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · Blackstone Medical, Inc. · Jun 2005