Cleared Special

K261112 - CastleLoc-P Anterior Cervical Plate System

K261112 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 33-day FDA review.

K261112 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
33d
Days
Class 2
Risk

K261112 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 May 6, 2026 after a review of 33 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

FDA 510(k) Submission Details - K261112

510(k) Number K261112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2026
Decision Date May 06, 2026
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 550
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K261112.
Palisades™ Buttress Plate System
K261309 · Bethesda Medical Devices, LLC · Jul 2026
ARIES Anterior Cervical Plate Systems
K252776 · ZheJiang Decans Medical Devices Co., Ltd. · May 2026
corra™ cervical plating system
K260570 · Carlsmed, Inc. · Apr 2026
VyPlate™ Anterior Cervical Plate System
K260697 · Vy Spine, LLC · Mar 2026
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026