Cleared Special

K162801 - CastleLoc Spinal Fixation System

K162801 is an FDA 510(k) clearance for CastleLoc Spinal Fixation System, manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 29-day FDA review.

K162801 · 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
Nov 2016
Decision
29d
Days
Class 2
Risk

K162801 is an FDA 510(k) clearance for the CastleLoc Spinal Fixation System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on November 3, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 - K162801

510(k) Number K162801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2016
Decision Date November 03, 2016
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K162801.
Reliance Spinal Screw System
K162066 · Reliance Medical Systems, LLC · Dec 2016
FixxSure® X-Link
K162143 · Innovasis, Inc. · Sep 2016
Spinal fixation system
K161151 · Canwell Medical Co., Ltd. · Sep 2016
ANAX™ 5.5 Spinal System
K162189 · U&I Corporation · Aug 2016
HC Spinal System
K151362 · Hung Chun Bio-S Co., Ltd. · May 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016
K162801 · CastleLoc Spinal Fixation System
Download PDF FDA Summary L & K Biomed Co., Ltd.