Cleared Traditional

EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM (K103490) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103490 · Johnson & Johnson · Orthopedic device
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Feb 2011
Decision
83d
Days
Class 2
Risk

K103490 is an FDA 510(k) clearance for the EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Johnson & Johnson (Raynham, US). The FDA issued a Cleared decision on February 17, 2011 after a review of 83 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 Johnson & Johnson devices

Submission Details

510(k) Number K103490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2010
Decision Date February 17, 2011
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 403
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K103490.
REVERE CROSSTOP
K111479 · Globus Medical, Inc. · Aug 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc. · Jul 2011
REVERE SACRAL PLATES
K103072 · Globus Medical, Inc. · Mar 2011
CD HORIZON SPINAL SYSTEM
K102555 · Medtronic Sofamor Danek USA, Inc. · Nov 2010
SYNTHES MATRIX SYSTEM
K100634 · Synthes (Usa) · Jul 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · Medtronic Sofamor Danek USA, Inc. · Jun 2010