Cleared Special

K110543 - CRESCENT (R) SPINAL SYSTEM TITANIUM

K110543 is an FDA 510(k) clearance for CRESCENT SPINAL SYSTEM TITANIUM, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 165-day FDA review.

K110543 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Aug 2011
Decision
165d
Days
Class 2
Risk

K110543 is an FDA 510(k) clearance for the CRESCENT (R) SPINAL SYSTEM TITANIUM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on August 9, 2011 after a review of 165 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, Inc. devices

FDA 510(k) Submission Details - K110543

510(k) Number K110543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date August 09, 2011
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K110543.
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
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K111166 · Spineworks, LLC · Sep 2011
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K111525 · Medtronic Sofamor Danek · Aug 2011
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CAPSTONE R SPINAL SYSTEM
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PLATEAU SPACER SYSTEM
K111569 · Life Spine · Jul 2011