Cleared Special

K240201 - PathLoc SI Joint Fusion System

K240201 is the FDA 510(k) clearance for PathLoc SI Joint Fusion System by L & K Biomed Co., Ltd.. It is a Class 2 Orthopedic device (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)
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.

View all L & K Biomed Co., Ltd. devices

Submission Details

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.

Device Classification

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 105
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