Cleared Traditional

K140276 - CD HORIZON SPINAL SYSTEM

K140276 is the FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code OSH) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K140276 · Medtronic Sofamor Danek · Orthopedic device
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Mar 2014
Decision
38d
Days
Class 2
Risk

K140276 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on March 13, 2014 after a review of 38 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 devices

Submission Details

510(k) Number K140276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date March 13, 2014
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.
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 - OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

All 10
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K140276.
RANGE SPINAL SYSTEM
K131784 · K2m, Inc. · Aug 2013
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K124058 · Globus Medical, Inc. · May 2013
RANGE SPINAL SYSTEM
K131030 · K2m, Inc. · May 2013
RANGE SPINAL SYSTEM, SMALL STATURE
K122877 · K2m, Inc. · May 2013
RESPONSE SPINE SYSTEM
K130655 · OrthoPediatrics Corp. · May 2013
RANGE SPINAL SYSTEM
K130330 · K2m, Inc. · May 2013