Cleared Traditional

K120353 - SYNSTER PEDICLE SCREW SYSTEM SYNSTER PL...

K120353 is an FDA 510(k) clearance for SYNSTER PEDICLE SCREW SYSTEM SYNSTER PL..., manufactured by Bm Korea Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K120353 · Bm Korea Co., Ltd. · Orthopedic device
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May 2012
Decision
93d
Days
Class 2
Risk

K120353 is an FDA 510(k) clearance for the SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Bm Korea Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on May 9, 2012 after a review of 93 days - within the typical 510(k) review window.

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 Bm Korea Co., Ltd. devices

FDA 510(k) Submission Details - K120353

510(k) Number K120353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date May 09, 2012
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 181
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K120353.
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K123164 · Spinefrontier, Inc. · Feb 2013
FORTEX PEDICLE SCREW SYSTEM
K120832 · X-Spine Systems, Inc. · Oct 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · K2m, Inc. · Jun 2012
TIGER SPINE SYSTEM
K110321 · Corelink, LLC · May 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · L & K Biomed Co., Ltd. · Feb 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · Ulrich GmbH & Co. KG · Jan 2011