Cleared Traditional

K123476 - MEGA 5.5 SPINE SYSTEM

K123476 is an FDA 510(k) clearance for MEGA 5.5 SPINE SYSTEM, manufactured by Lsk Biopartners, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K123476 · Lsk Biopartners, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
56d
Days
Class 2
Risk

K123476 is an FDA 510(k) clearance for the MEGA 5.5 SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Lsk Biopartners, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 8, 2013 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K123476

510(k) Number K123476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date January 08, 2013
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K123476.
INTRAMEDULLARY NAIL SYSTEM
K122994 · Weigao Orthopaedic Device Co., Ltd. · Apr 2013
GSO GS1 CANNULATED SCREW SYSTEM
K123487 · Gold Standard Orthopaedics, LLC · Mar 2013
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K123164 · Spinefrontier, Inc. · Feb 2013
INSTINCT JAVA SYSTEM
K122592 · Zimmer Spine · Jan 2013
GALLEON PEDICLE SCREW SYSTEM
K122814 · Everest Spine, LLC · Dec 2012
FORTEX PEDICLE SCREW SYSTEM
K120832 · X-Spine Systems, Inc. · Oct 2012
K123476 · MEGA 5.5 SPINE SYSTEM
Download PDF FDA Summary Lsk Biopartners, Inc.