Cleared Traditional

K152457 - CD HORIZON Spinal System

K152457 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 60-day FDA review.

K152457 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Oct 2015
Decision
60d
Days
Class 2
Risk

K152457 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 October 27, 2015 after a review of 60 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

FDA 510(k) Submission Details - K152457

510(k) Number K152457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2015
Decision Date October 27, 2015
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 K152457.
Polaris Spinal System
K151974 · Biomet Spine · Nov 2015
CD HORIZON Spinal System
K152248 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Genesys Spine TiLock2 Spinal System
K152039 · Genesys Spine · Oct 2015
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
K151648 · Altus Partners, LLC · Oct 2015
STERISPINE PS
K151921 · Safe Orthopaedics · Oct 2015
STERISPINE PS
K151747 · Safe Orthopaedics · Oct 2015