Cleared Special

K231839 - CastleLoc-P Anterior Cervical Plate System

K231839 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.

K231839 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
27d
Days
Class 2
Risk

K231839 is an FDA 510(k) clearance for the CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar 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 July 19, 2023 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 K231839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2023
Decision Date July 19, 2023
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 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K231839.
VICTORY™ Lumbar Plate System
K232318 · Globus Medical, Inc. · Oct 2023
Skyway Anterior Cervical Plate System
K231766 · Kyocera Medical Technologies Inc. (KMTI) · Sep 2023
Sapphire X3 Anterior Cervical Plate System
K231593 · Spinal Elements, Inc. · Aug 2023
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System
K231460 · K&J Consulting Corp. · Jul 2023
CODA™ Anterior Cervical Plate System
K230993 · Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · Jun 2023
Zevo Anterior Cervical Plate System
K231090 · Medtronic Sofamor Danek USA, Inc. · Jun 2023