Cleared Traditional

K092474 - PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS

K092474 is an FDA 510(k) clearance for PYRENEES CERVICAL PLATE SYSTEM, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K092474 · K2m, Inc. · Orthopedic device
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Mar 2010
Decision
211d
Days
Class 2
Risk

K092474 is an FDA 510(k) clearance for the PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on March 11, 2010 after a review of 211 days - an extended review 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: 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, Inc. devices

FDA 510(k) Submission Details - K092474

510(k) Number K092474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2009
Decision Date March 11, 2010
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K092474.
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614 · Blackstone Medical, Inc. · May 2010
LANX ANTERIOR PLATING SYSTEM
K092765 · Lanx, Inc. · Apr 2010
INDUS ANTERIOR CERVICAL PLATE SYSTEM
K093776 · Spinefrontier, Inc. · Mar 2010
NUVASIVE HELIX REVOLUTION ACP SYSTEM
K093804 · Nuvasive, Inc. · Feb 2010
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
K100061 · K2m, Inc. · Feb 2010
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K100070 · Depuy Spine, Inc. · Feb 2010