Cleared Special

K231839 - CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

K231839 is an FDA 510(k) clearance for CastleLoc-P Anterior Cervical Plate System, manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K231839

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.

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 667
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
K231839 · CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
Download PDF FDA Summary L & K Biomed Co., Ltd.