Cleared Special

K043001 - MX POLYAXIAL PEDICLE SCREW

K043001 is an FDA 510(k) clearance for MX POLYAXIAL PEDICLE SCREW, manufactured by Scient'X. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 30-day FDA review.

K043001 · Scient'X · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
30d
Days
Class 2
Risk

K043001 is an FDA 510(k) clearance for the MX POLYAXIAL PEDICLE SCREW. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Scient'X (Round Rock, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 30 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K043001

510(k) Number K043001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date December 01, 2004
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K043001.
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K042928 · U&I Corp. · Feb 2005
VERTEBRON PSS PEDICLE SCREW SYSTEM
K043152 · Vertebron, Inc. · Feb 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · Medtronic Sofamor Danek · Dec 2004
UNI-THREAD SPINAL SYSTEM
K042640 · Spine Vision, Inc. · Nov 2004
MX MONOAXIAL PEDICLE SCREW
K042964 · Scient'X · Nov 2004
ALADYN RIGID SPINE PLATE
K040747 · Scient'X · Jun 2004
K043001 · MX POLYAXIAL PEDICLE SCREW
Download PDF FDA Summary Scient'X