Cleared Traditional

K112724 - DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM

K112724 is the FDA 510(k) clearance for DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM by Medos International SARL. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K112724 · Medos International SARL · Orthopedic device
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Nov 2011
Decision
63d
Days
Class 2
Risk

K112724 is an FDA 510(k) clearance for the DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medos International SARL (Raynham, US). The FDA issued a Cleared decision on November 21, 2011 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medos International SARL devices

Submission Details

510(k) Number K112724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2011
Decision Date November 21, 2011
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K112724.
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · L & K Biomed Co., Ltd. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
K111132 · Genesys Spine · Dec 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · Zimmer Spine, Inc. · Oct 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · K2m, Inc. · Aug 2011
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866 · Nuvasive, Inc. · Jul 2011