Cleared Special

K080394 - BLACKSTONE ASCENT POSTERIOR OCCIPITAL C...

K080394 is the FDA 510(k) clearance for BLACKSTONE ASCENT POSTERIOR OCCIPITAL C... 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.

K080394 · Blackstone Medical, Inc. · Orthopedic device
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Mar 2008
Decision
29d
Days
Class 2
Risk

K080394 is an FDA 510(k) clearance for the BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Wayne, US). The FDA issued a Cleared decision on March 13, 2008 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 K080394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date March 13, 2008
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 K080394.
VERTEX RECONSTRUCTION SYSTEM
K081297 · Medtronic Sofamor Danek · Jun 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K080805 · Medtronic Sofamor Danek · Apr 2008
SPINOUS PROCESS PLATE SYSTEM
K073278 · Nuvasive, Inc. · Mar 2008
BLACKSTONE ASCENT MULTIAXIAL SCREWS
K073420 · Blackstone Medical, Inc. · Feb 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · Blackstone Medical, Inc. · Jan 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K071942 · Medtronic Sofamor Danek · Dec 2007