Cleared Traditional

K051531 - TECTONIC CERVICAL PLATE SYSTEM

K051531 is an FDA 510(k) clearance for TECTONIC CERVICAL PLATE SYSTEM, manufactured by K2m, LLC. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K051531

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
Combination Product No
PCCP Authorized No
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.

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 583
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K051531.
AEGIS ANTERIOR LUMBAR PLATE SYSTEM
K052546 · Depuy Spine, Inc. · Feb 2006
PACP SYSTEM
K053053 · Pioneer Surgical Technology · Nov 2005
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · X-Spine Systems, Inc. · Oct 2005
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K051815 · Vertebron, Inc. · Oct 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005
SYNTHES VECTRA-T SYSTEM
K051665 · Synthes Spine · Sep 2005