Cleared Special

K240201 - PathLoc SI Joint Fusion System

K240201 is an FDA 510(k) clearance for PathLoc SI Joint Fusion System, manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Special 510(k) pathway after a 29-day FDA review.

K240201 · 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
Feb 2024
Decision
29d
Days
Class 2
Risk

K240201 is an FDA 510(k) clearance for the PathLoc SI Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on February 23, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K240201

510(k) Number K240201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2024
Decision Date February 23, 2024
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.

OUR Device Classification - Class 2, Special Controls

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
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 - OUR Sacroiliac Joint Fixation

All 132
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K240201.
Patriot-SI Posterior Implant System
K232259 · Spinal Simplicity, LLC · Apr 2024
TiLink-P SI Joint Fusion System
K240720 · SurGenTec, LLC · Apr 2024
Camber Sacroiliac (SI) Fixation System
K233972 · Camber Spine Technologies · Feb 2024
iFuse Bedrock Granite® Implant System
K233508 · SI-BONE, Inc. · Jan 2024
TORPEDO Implant System®
K230817 · Deltacor GmbH · Jan 2024
Liberty SI Lateral Implant System
K231923 · Spinal Simplicity, LLC · Dec 2023
K240201 · PathLoc SI Joint Fusion System
Download PDF FDA Summary L & K Biomed Co., Ltd.