Cleared Traditional

K151553 - Anterior Cervical Plate System

K151553 is an FDA 510(k) clearance for Anterior Cervical Plate System, manufactured by Osteomed Implantes, Ltda. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K151553 · Osteomed Implantes, Ltda · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
246d
Days
Class 2
Risk

K151553 is an FDA 510(k) clearance for the Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Osteomed Implantes, Ltda (Rio Claro - Sp, BR). The FDA issued a Cleared decision on February 10, 2016 after a review of 246 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151553

510(k) Number K151553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2015
Decision Date February 10, 2016
Days to Decision 246 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
124d slower than avg
Panel avg: 122d · This submission: 246d
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 K151553.
White Pearl Preferred Angle Anterior Cervical Plate
K160522 · Osseus Fusion Systems, LLC · Apr 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016
Z-Span Plate System
K160362 · Zavation, LLC · Mar 2016
Zero-P Natural Plate System
K152239 · Synthes (Usa), LLC · Dec 2015
Cam Lock Plating System
K152282 · Life Spine, Inc. · Nov 2015
ATLANTIS Anterior Cervical Plate System
K152623 · Medtronic Sofamor Danek USA, Inc. · Nov 2015