Cleared Traditional

K020674 - BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM...

K020674 is the FDA 510(k) clearance for BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K020674 · Blackstone Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2002
Decision
33d
Days
Class 2
Risk

K020674 is an FDA 510(k) clearance for the BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on April 3, 2002 after a review of 33 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Blackstone Medical, Inc. devices

Submission Details

510(k) Number K020674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date April 03, 2002
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K020674.
EQUATION FIXATION SYSTEM
K013962 · Medtronic Sofamor Danek, Inc. · Jun 2002
TSRH SPINAL SYSTEM
K020699 · Medtronic Sofamor Danek, Inc. · May 2002
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
K021148 · Depuyacromed · May 2002
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681 · Ebi, L.P. · Apr 2002
OSTEONICS SPINAL SYSTEM
K020293 · Howmedica Osteonics Corp. · Feb 2002
BACFIX SPINAL FIXATION SYSTEM
K013887 · Spinal Concepts, Inc. · Feb 2002