Cleared Traditional

K160522 - White Pearl Preferred Angle Anterior Cervical Plate

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

The OrthoMedix Group, Inc.
J. D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 657
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K160522.
Belvedere™ Lateral Plating System
K153097 · Neurostructures, Inc. · Jul 2016
Cure™ Anterior Cervical Plate (ACP) System
K160604 · Meditech Spine, LLC · Jul 2016
Pyrenees Cervical Plate System
K153526 · K2m · Apr 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016
Z-Span Plate System
K160362 · Zavation, LLC · Mar 2016
Anterior Cervical Plate System
K151553 · Osteomed Implantes, Ltda · Feb 2016