Cleared Special

K190425 - CastleLoc-P Anterior Cervical Plate System

K190425 is the FDA 510(k) clearance for CastleLoc-P Anterior Cervical Plate System by L & K Biomed Co., Ltd.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 27-day FDA review.

K190425 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
27d
Days
Class 2
Risk

K190425 is an FDA 510(k) clearance for the CastleLoc-P Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on March 21, 2019 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all L & K Biomed Co., Ltd. devices

Submission Details

510(k) Number K190425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2019
Decision Date March 21, 2019
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K190425.
CYGNUS™ Anterior Cervical Plate System
K190666 · MiRus, LLC · May 2019
Boomerang™ Anterior Cervical Plate System
K190227 · Choicespine, LP · May 2019
ASSURE® Anterior Cervical Plate System
K183056 · Globus Medical, Inc. · Apr 2019
SMG Anterior Cervical Plate System
K183073 · Sapphire Medical Group · Feb 2019
Athena II Cervical Plate System
K183409 · Medyssey USA, Inc. · Feb 2019
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 · Medtronic Sofamor Danek USA, Inc. · Feb 2019