Cleared Traditional

K111510 - CD HORIZON SPINAL SYSTEM

K111510 is the FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K111510 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Sep 2011
Decision
106d
Days
Class 2
Risk

K111510 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 September 15, 2011 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K111510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 01, 2011
Decision Date September 15, 2011
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 K111510.
CD HORIZON SPINAL SYSTEM
K112473 · Medtronic Sofamor Danek, Inc. · Oct 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · Medtronic Sofamor Danek USA, Inc. · Sep 2011
CD HORIZON SPINAL SYSTEM
K111457 · Medtronic Sofamor Danek · Sep 2011
PILOT SPINAL SYSTEM
K111729 · Life Spine, Inc. · Sep 2011
TSRH SPINAL SYSTEMS
K111942 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
REVOLVE ADDITIONAL IMPLANTS
K111449 · Globus Medical, Inc. · Aug 2011