Cleared Special

K181600 - PathLoc-SI Joint Fusion System

K181600 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 28-day FDA review.

K181600 · 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 2018
Decision
28d
Days
Class 2
Risk

K181600 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 July 16, 2018 after a review of 28 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 - K181600

510(k) Number K181600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2018
Decision Date July 16, 2018
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K181600.
SI-Restore® Sacroiliac Joint Fixation System
K182919 · Biofusion Medical · Jan 2019
iFuse Implant System®
K182983 · SI-BONE, Inc. · Nov 2018
Outlet Sacroiliac Joint Fusion System
K181881 · Sij Surgical · Oct 2018
Life Spine SIMPACT Sacroiliac Joint Fixation System
K180749 · Life Spine, Inc. · Jun 2018
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
K180818 · Tenon Medical, Inc. · Jun 2018
UNITY Sacroiliac Joint Fixation System
K173201 · Huvexel Co. , Ltd. · Apr 2018
K181600 · PathLoc-SI Joint Fusion System
Download PDF FDA Summary L & K Biomed Co., Ltd.