Cleared Special

K131321 - CD HORIZON SPINAL SYSTEM

K131321 is an FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek USA. The device is a Class 2 Orthopedic device with product code OSH cleared through the Special 510(k) pathway after a 28-day FDA review.

K131321 · Medtronic Sofamor Danek USA · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
28d
Days
Class 2
Risk

K131321 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 USA (Memphis, US). The FDA issued a Cleared decision on June 5, 2013 after a review of 28 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.

FDA 510(k) Submission Details - K131321

510(k) Number K131321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2013
Decision Date June 05, 2013
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

OSH Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K131321.
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
K131802 · Depuy Spine, A Johnson & Johnson Company · Sep 2013
POLARIS SPINAL SYSTEM
K131615 · Biomet Spine (Aka Ebi, LLC) · Sep 2013
RANGE SPINAL SYSTEM
K131784 · K2m, Inc. · Aug 2013
CREO STABILIZATION SYSTEM
K124058 · Globus Medical, Inc. · May 2013
RANGE SPINAL SYSTEM
K131030 · K2m, Inc. · May 2013
RANGE SPINAL SYSTEM, SMALL STATURE
K122877 · K2m, Inc. · May 2013
K131321 · CD HORIZON SPINAL SYSTEM
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