Cleared Traditional

K153656 - PathLoc-SI Joint Fusion System

K153656 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 Traditional 510(k) pathway after a 329-day FDA review.

K153656 · L & K Biomed Co., Ltd. · Orthopedic device
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Nov 2016
Decision
329d
Days
Class 2
Risk

K153656 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. (Giheung-Gu, Yongin-Si, KR). The FDA issued a Cleared decision on November 14, 2016 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K153656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date November 14, 2016
Days to Decision 329 days
Submission Type Traditional
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
207d slower than avg
Panel avg: 122d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 118
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K153656.
SI Screw System
K173752 · Zavation Medical Products, LLC · Mar 2018
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595 · Medacta International S.A. · Aug 2017
iFuse Implant System® - iFuse-3D implant
K162733 · SI-BONE, Inc. · Mar 2017
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
K161210 · Medtronic Sofamor Danek · Aug 2016
iFUSE Implant System
K160652 · SI-BONE, Inc. · Jun 2016
iFuse Implant System(R)
K152681 · SI-BONE, Inc. · Mar 2016