Cleared Traditional

K182885 - Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System

K182885 is an FDA 510(k) clearance for Atlantis Anterior Cervical Plate, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K182885 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
114d
Days
Class 2
Risk

K182885 is an FDA 510(k) clearance for the Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion Syste.... Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on February 6, 2019 after a review of 114 days - within the typical 510(k) review window.

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.

View all Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K182885

510(k) Number K182885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2018
Decision Date February 06, 2019
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
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 594
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K182885.
CastleLoc-P Anterior Cervical Plate System
K190425 · L & K Biomed Co., Ltd. · Mar 2019
SMG Anterior Cervical Plate System
K183073 · Sapphire Medical Group · Feb 2019
Athena II Cervical Plate System
K183409 · Medyssey USA, Inc. · Feb 2019
SECULOK™ ACP System
K190053 · U&I Corporation · Feb 2019
Pinehurst Anterior Cervical Plate System
K181190 · Signature Orthopaedics Pty, Ltd. · Jan 2019
CervAlign™ Anterior Cervical Plate System
K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jan 2019