Cleared Special

K042514 - MODIFICATION TO BLACKSTONE MODULAR PEDI...

K042514 is the FDA 510(k) clearance for MODIFICATION TO BLACKSTONE MODULAR PEDI... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 21-day FDA review.

K042514 · Blackstone Medical, Inc. · Orthopedic device
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Oct 2004
Decision
21d
Days
Class 2
Risk

K042514 is an FDA 510(k) clearance for the MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on October 7, 2004 after a review of 21 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.

View all Blackstone Medical, Inc. devices

Submission Details

510(k) Number K042514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2004
Decision Date October 07, 2004
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K042514.
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675 · Depuy Spine, Inc. · Apr 2005
MSD SILO SPINAL SYSTEM
K042210 · Medtronic Sofamor Danek · Nov 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · Medtronic Sofamor Danek, Inc. · Oct 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100 · Blackstone Medical, Inc. · Sep 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777 · Medtronic Sofamor Danek · Sep 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030 · Medtronic Sofamor Danek · Jun 2004