Cleared Traditional

K160522 - White Pearl Preferred Angle Anterior Ce...

K160522 is an FDA 510(k) clearance for White Pearl Preferred Angle Anterior Ce..., manufactured by Osseus Fusion Systems, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K160522 · Osseus Fusion Systems, LLC · Orthopedic device
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Apr 2016
Decision
61d
Days
Class 2
Risk

K160522 is an FDA 510(k) clearance for the White Pearl Preferred Angle Anterior Cervical Plate. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Osseus Fusion Systems, LLC (Dallas, US). The FDA issued a Cleared decision on April 26, 2016 after a review of 61 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 Osseus Fusion Systems, LLC devices

FDA 510(k) Submission Details - K160522

510(k) Number K160522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2016
Decision Date April 26, 2016
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 484
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K160522.
AccuFit Lateral Plate System
K162211 · Precision Spine, Inc. · Nov 2016
Pyrenees Cervical Plate System
K162664 · K2m, Inc. · Oct 2016
ZION Anterior Cervical Fixation System
K160702 · Astura Medical · Aug 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016
Cam Lock Plating System
K152282 · Life Spine, Inc. · Nov 2015
ATLANTIS Anterior Cervical Plate System
K152623 · Medtronic Sofamor Danek USA, Inc. · Nov 2015