Cleared Special

K113528 - CLYDESDALE SPINAL SYSTEM

K113528 is the FDA 510(k) clearance for CLYDESDALE SPINAL SYSTEM by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 20-day FDA review.

K113528 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Dec 2011
Decision
20d
Days
Class 2
Risk

K113528 is an FDA 510(k) clearance for the CLYDESDALE(R) SPINAL SYSTEM. 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 December 20, 2011 after a review of 20 days - a notably fast clearance 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. 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.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K113528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date December 20, 2011
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K113528.
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
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K113138 · K2m, Inc. · Jan 2012
CLYDESDALES SPINAL SYSTEM
K112405 · Medtronic Sofamor Danek USA, Inc. · Nov 2011
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
K110783 · L & K Biomed Co., Ltd. · Oct 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880 · Spineology, Inc. · Sep 2011