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) Official FDA 510(k) Summary (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.

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 308
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
K133153 · SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
Download PDF FDA Summary Spinefrontier, Inc.