Cleared Traditional

K142591 - CD HORIZON Spinal System

K142591 is the FDA 510(k) clearance for CD HORIZON Spinal System by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K142591 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Dec 2014
Decision
77d
Days
Class 2
Risk

K142591 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 USA, Inc. (Memphis, US). The FDA issued a Cleared decision on December 1, 2014 after a review of 77 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 USA, Inc. devices

Submission Details

510(k) Number K142591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2014
Decision Date December 01, 2014
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 K142591.
MAS PLIF Fixation system
K142737 · Nu Vasive, Incorporated · Dec 2014
Threshold Pedicular Fixation System
K143403 · Spineology, Inc. · Dec 2014
IBIS PEDICLE SCREW SYSTEM
K142146 · Ortho Development Corp. · Dec 2014
CD HORIZON Spinal System
K143141 · Medtronic Sofamor Danek USA, Inc. · Dec 2014
EXPEDIUM VERSE SPINE SYSTEM
K142185 · Depuy Spine, Inc. · Nov 2014
Reline System
K142499 · Nu Vasive, Incorporated · Nov 2014