Cleared Traditional

K102406 - PASS ANTERIOR SPINAL SYSTEM

K102406 is an FDA 510(k) clearance for PASS ANTERIOR SPINAL SYSTEM, manufactured by Medicrea Technologies. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K102406 · Medicrea Technologies · Orthopedic device
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Aug 2011
Decision
364d
Days
Class 2
Risk

K102406 is an FDA 510(k) clearance for the PASS ANTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medicrea Technologies (Round Rock, US). The FDA issued a Cleared decision on August 23, 2011 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medicrea Technologies devices

FDA 510(k) Submission Details - K102406

510(k) Number K102406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2010
Decision Date August 23, 2011
Days to Decision 364 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
242d slower than avg
Panel avg: 122d · This submission: 364d
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 505
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K102406.
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · Medos International SARL · Nov 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · Zimmer Spine, Inc. · Oct 2011
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K111528 · Pioneer Surgical Technology, Inc. · Aug 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · K2m, Inc. · Aug 2011
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866 · Nuvasive, Inc. · Jul 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410 · Nuvasive, Inc. · Jun 2011