Cleared Traditional

K143019 - CD HORIZON Spinal System, IPC POWEREASE System

K143019 is an FDA 510(k) clearance for CD HORIZON Spinal System, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K143019 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2015
Decision
170d
Days
Class 2
Risk

K143019 is an FDA 510(k) clearance for the CD HORIZON Spinal System, IPC POWEREASE 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 April 8, 2015 after a review of 170 days - an extended review 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: 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 USA, Inc. devices

FDA 510(k) Submission Details - K143019

510(k) Number K143019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date April 08, 2015
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K143019.
NuVasive Reline System
K143684 · Nu Vasive, Incorporated · Apr 2015
VENUS Spinal Fixation System
K143363 · L & K Biomed Co., Ltd. · Apr 2015
IMPLANET Spine System (ISS)
K143731 · Implanet, S.A. · Apr 2015
Santis Pedicle Screw System
K150507 · Lanterna Medical Technologies · Apr 2015
Range/Denali/Mesa Spinal System
K150325 · K2m, Inc. · Mar 2015
F1-Modular Pedicle Screw System
K142531 · Degen Medical · Mar 2015