Cleared Special

K182119 - CD HORIZON Spinal System

K182119 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 Special 510(k) pathway after a 23-day FDA review.

K182119 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Aug 2018
Decision
23d
Days
Class 2
Risk

K182119 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 August 29, 2018 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K182119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2018
Decision Date August 29, 2018
Days to Decision 23 days
Submission Type Special
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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K182119.
Chiral Surgical Pedicle Screw System
K181995 · Chiral Surgical · Sep 2018
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
K181390 · OrthoPediatrics Corp. · Sep 2018
MOSS VRS Spinal System
K181821 · Biedermann Motech GmbH & Co. KG · Sep 2018
Firebird® Spinal Fixation Systems: Firebird System
K180179 · Orthofix, Inc. · Aug 2018
Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
K181978 · Medyssey USA, Inc. · Aug 2018
Redi-Spine
K181584 · Innovative Surgical Designs, Inc. · Aug 2018