Cleared Special

K022605 - BLACKSTONE SPINAL FIXATION SYSTEM STAPL...

K022605 is the FDA 510(k) clearance for BLACKSTONE SPINAL FIXATION SYSTEM STAPL... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 15-day FDA review.

K022605 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Aug 2002
Decision
15d
Days
Class 2
Risk

K022605 is an FDA 510(k) clearance for the BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on August 21, 2002 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 K022605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2002
Decision Date August 21, 2002
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K022605.
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · Spinal Concepts, Inc. · Oct 2002
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K023133 · Ebi, L.P. · Oct 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · Medtronic Sofamor Danek · Sep 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · Ebi, L.P. · Aug 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399 · Blackstone Medical, Inc. · Aug 2002
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
K021461 · Medtronic Sofamor Danek · Jul 2002