Cleared Special

K111264 - CORNERSTONE PSR CERVICAL FUSION SYSTEM

K111264 is the FDA 510(k) clearance for CORNERSTONE PSR CERVICAL FUSION SYSTEM by Medtronic Sofamor Danek USA. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 161-day FDA review.

K111264 · Medtronic Sofamor Danek USA · Orthopedic device
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Oct 2011
Decision
161d
Days
Class 2
Risk

K111264 is an FDA 510(k) clearance for the CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA (Memphis, US). The FDA issued a Cleared decision on October 12, 2011 after a review of 161 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek USA devices

Submission Details

510(k) Number K111264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2011
Decision Date October 12, 2011
Days to Decision 161 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 220
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K111264.
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K112862 · Medacta International · Dec 2011
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K103655 · Exactech, Inc. · Jun 2011