Cleared Special

K030241 - MODIFICATION TO BLACKSTONE SPINAL FIXAT...

K030241 is the FDA 510(k) clearance for MODIFICATION TO BLACKSTONE SPINAL FIXAT... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 29-day FDA review.

K030241 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2003
Decision
29d
Days
Class 2
Risk

K030241 is an FDA 510(k) clearance for the MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 K030241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2003
Decision Date February 21, 2003
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K030241.
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · Blackstone Medical, Inc. · Jun 2003
MSD CABLE REDUCTION SYSTEM
K030816 · Medtronic Sofamor Danek · Jun 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · Howmedica Osteonics Corp. · Apr 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · Depuyacromed · Jan 2003
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · Medtronic Sofamor Danek · Dec 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · Medtronic Sofamor Danek · Dec 2002