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
Combination Product No
PCCP Authorized No
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 Consultant

Withus Group, Inc.
APRIL LEE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MNI Orthosis, Spinal Pedicle Fixation

All 290
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K160731.
Mikron Spinal Fixation System
K171497 · Mikron Makina Sanayi Ticaret Co. , Ltd. · Oct 2017
Double Medical Universal Spine System
K151458 · Double Medical Technology, Inc. · Aug 2016
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
K160124 · Spinevision S.A. · Apr 2016
Premier
K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · Apr 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016