Cleared Traditional

K123164 - SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM

K123164 is the FDA 510(k) clearance for SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM by Spinefrontier, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K123164 · Spinefrontier, Inc. · Orthopedic device
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Feb 2013
Decision
129d
Days
Class 2
Risk

K123164 is an FDA 510(k) clearance for the SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on February 15, 2013 after a review of 129 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 Spinefrontier, Inc. devices

Submission Details

510(k) Number K123164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2012
Decision Date February 15, 2013
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 118
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K123164.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · Spineart · May 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403 · Spine Wave, Inc. · Jan 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267 · Spineart · May 2013
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · K2m, Inc. · Jun 2012
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · L & K Biomed Co., Ltd. · Feb 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · Exactech, Inc. · Jan 2011