Cleared Traditional

K042210 - MSD SILO SPINAL SYSTEM

K042210 is the FDA 510(k) clearance for MSD SILO SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K042210 · Medtronic Sofamor Danek · Orthopedic device
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Nov 2004
Decision
80d
Days
Class 2
Risk

K042210 is an FDA 510(k) clearance for the MSD SILO SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on November 4, 2004 after a review of 80 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K042210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2004
Decision Date November 04, 2004
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K042210.
S4 SPINAL SYSTEM
K050979 · Aesculap, Inc. · Jul 2005
CD HORIZON SPINAL SYSTEM
K050981 · Medtronic Sofamor Danek USA, Inc. · May 2005
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675 · Depuy Spine, Inc. · Apr 2005
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · Medtronic Sofamor Danek, Inc. · Oct 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514 · Blackstone Medical, Inc. · Oct 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100 · Blackstone Medical, Inc. · Sep 2004