Cleared Traditional

K013558 - BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW

K013558 is an FDA 510(k) clearance for BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM..., manufactured by Blackstone Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013558 · Blackstone Medical, Inc. · Orthopedic device
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Jan 2002
Decision
90d
Days
Class 2
Risk

K013558 is an FDA 510(k) clearance for the BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW. 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 January 23, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Blackstone Medical, Inc. devices

FDA 510(k) Submission Details - K013558

510(k) Number K013558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2001
Decision Date January 23, 2002
Days to Decision 90 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K013558.
ENDIUS CERVICAL PLATE SYSTEM
K014107 · Endius, Inc. · Feb 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184 · Blackstone Medical, Inc. · Jan 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665 · Medtronic Sofamor Danek, Inc. · Jan 2002
CODMAN SLIM-LOC SYSTEM
K013877 · Codman & Shurtleff, Inc. · Dec 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc. · Nov 2001
MACROPORE OS SPINAL SYSTEM
K010911 · Macropore Biosurgery, Inc. · Jul 2001