Cleared Special

K121764 - CD HORIZON SPINAL SYSTEM

K121764 is an FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 67-day FDA review.

K121764 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
67d
Days
Class 2
Risk

K121764 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, Inc. (Memphis, US). The FDA issued a Cleared decision on August 21, 2012 after a review of 67 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, Inc. devices

FDA 510(k) Submission Details - K121764

510(k) Number K121764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 15, 2012
Decision Date August 21, 2012
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

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 882
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K121764.
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