Cleared Traditional

K133518 - MAXAN ANTERIOR CERVICAL PLATE SYSTEM

K133518 is an FDA 510(k) clearance for MAXAN ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Biomet Spine (Aka Ebi, LLC). The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K133518 · Biomet Spine (Aka Ebi, LLC) · Orthopedic device
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Nov 2014
Decision
355d
Days
Class 2
Risk

K133518 is an FDA 510(k) clearance for the MAXAN ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on November 5, 2014 after a review of 355 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 Biomet Spine (Aka Ebi, LLC) devices

FDA 510(k) Submission Details - K133518

510(k) Number K133518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2013
Decision Date November 05, 2014
Days to Decision 355 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
233d slower than avg
Panel avg: 122d · This submission: 355d
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 491
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K133518.
NuVasive ALIF Buttress Plate System
K143065 · Nu Vasive, Incorporated · Jan 2015
LITe Plate System
K142699 · Stryker Corporation · Dec 2014
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · Medtronic Sofamor Danek USA, Inc. · Dec 2014
GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM
K133245 · Genesys Spine · Oct 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K141500 · Zimmer Spine, Inc. · Sep 2014
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
K133911 · Genesys Spine · Sep 2014