Cleared Special

K090224 - FORTEX PEDICLE SCREW SYSTEM

K090224 is an FDA 510(k) clearance for FORTEX PEDICLE SCREW SYSTEM, manufactured by X-Spine Systems, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 181-day FDA review.

K090224 · X-Spine Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
181d
Days
Class 2
Risk

K090224 is an FDA 510(k) clearance for the FORTEX PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 181 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 - K090224

510(k) Number K090224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2009
Decision Date July 30, 2009
Days to Decision 181 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
59d slower than avg
Panel avg: 122d · This submission: 181d
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 K090224.
NORM SPINAL SYSTEM
K092011 · Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar · Oct 2009
ULC SPINAL PEDICLE SCREW SYSTEM
K083077 · Otis Biotech Co., Ltd. · Oct 2009
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW
K083567 · Co-Ligne AG · Sep 2009
ALPINE PEDICLE SCREW SYSTEM
K090477 · Sanacor · Jul 2009
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
K091110 · Spinal Edge, LLC · Jul 2009
DVX SPINE SYSTEM
K090424 · Bk Meditech, Co., Ltd. · May 2009
K090224 · FORTEX PEDICLE SCREW SYSTEM
Download PDF FDA Summary X-Spine Systems, Inc.