Cleared Traditional

K091445 - CD HORIZON SPINAL SYSTEM

K091445 is the FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 500-day FDA review.

K091445 · Medtronic Sofamor Danek · Orthopedic device
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Sep 2010
Decision
500d
Days
Class 2
Risk

K091445 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on September 27, 2010 after a review of 500 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K091445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 15, 2009
Decision Date September 27, 2010
Days to Decision 500 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
378d slower than avg
Panel avg: 122d · This submission: 500d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K091445.
MODIFICATION TO:EXPEDIUM SPINE SYSTEM
K101933 · Depuy Spine, Inc. · Oct 2010
EXCELLA II SPINAL SYSTEM MODEL EC2-00
K102248 · Innovasis, Inc. · Oct 2010
TSRH(R) SPINAL SYSTEM
K101772 · Medtronic Sofamor Danek · Sep 2010
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
K100845 · Zimmer Spine, Inc. · Sep 2010
EXPEDIUM SPINE SYSTEM
K101070 · Medos International SARL · Aug 2010
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
K102235 · Stryker Spine · Aug 2010