Cleared Traditional

K160731 - LumFix Spinal Fixation Sytem

K160731 is an FDA 510(k) clearance for LumFix Spinal Fixation Sytem, manufactured by CG Bio Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K160731 · CG Bio Co., Ltd. · Orthopedic device
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Oct 2016
Decision
201d
Days
Class 2
Risk

K160731 is an FDA 510(k) clearance for the LumFix Spinal Fixation Sytem. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by CG Bio Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 4, 2016 after a review of 201 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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. Standard predicate reliance. 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 CG Bio Co., Ltd. devices

FDA 510(k) Submission Details - K160731

510(k) Number K160731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2016
Decision Date October 04, 2016
Days to Decision 201 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 122d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 187
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K160731.
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
X-spine Pedicle Screw System
K152132 · X-Spine Systems, Inc. · Sep 2015
Reliance Spinal Screw System
K152131 · Reliance Medical Systems, LLC · Sep 2015
Sniper Spine System
K152174 · Spine Wave, Inc. · Aug 2015
Sniper Spine System
K151813 · Spine Wave, Inc. · Jul 2015