Cleared Special

K231841 - PathLoc SI Joint Fusion System

K231841 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 22-day FDA review.

K231841 · 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 2023
Decision
22d
Days
Class 2
Risk

K231841 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 14, 2023 after a review of 22 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 - K231841

510(k) Number K231841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2023
Decision Date July 14, 2023
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
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 K231841.
Xenix Medical Sacroiliac Fixation System
K231829 · Ht Medical D.B.A. Xenix Medical · Aug 2023
TiLink-L Joint Fusion System
K231831 · Surgentec · Aug 2023
SI-Cure Sacroiliac Joint Fusion System
K231951 · Alevio, LLC · Jul 2023
iFuse TORQ® Implant System
K231689 · SI-BONE, Inc. · Jun 2023
TiLink-L SI Joint Fusion System
K230446 · SurGenTec, LLC · Jun 2023
Kisar Stratford SI Screw System
K220274 · Anjali Investments L.L.C · Apr 2023
K231841 · PathLoc SI Joint Fusion System
Download PDF FDA Summary L & K Biomed Co., Ltd.