Cleared Special

K133153 - SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM

K133153 is an FDA 510(k) clearance for SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM, manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 209-day FDA review.

K133153 · Spinefrontier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
209d
Days
Class 2
Risk

K133153 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 May 14, 2014 after a review of 209 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spinefrontier, Inc. devices

FDA 510(k) Submission Details - K133153

510(k) Number K133153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date May 14, 2014
Days to Decision 209 days
Submission Type Special
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
87d slower than avg
Panel avg: 122d · This submission: 209d
Pathway characteristics
Modification to existing cleared device.

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 231
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K133153.
COSMOLOCK PEDICLE SCREW SYSTEM
K140678 · Kalitec Direct, LLC · Jun 2014
PLS (POSTERIOR LUMBAR SYSTEM)
K140787 · Sintea Plustek, LLC · May 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · Spineart · May 2014
TRUE SPINAL FUSSION SYSTEM
K133690 · Innovative Surgical Designs · May 2014
PRESSON SPINAL FIXATION SYSTEM
K133287 · Nexus Spine, LLC · Feb 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403 · Spine Wave, Inc. · Jan 2014