Cleared Special

K050117 - MODIFICATION TO PYRAMID ANTERIOR PLATE ...

K050117 is the FDA 510(k) clearance for MODIFICATION TO PYRAMID ANTERIOR PLATE ... by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K050117 · Medtronic Sofamor Danek · Orthopedic device
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Feb 2005
Decision
30d
Days
Class 2
Risk

K050117 is an FDA 510(k) clearance for the MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on February 17, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 devices

Submission Details

510(k) Number K050117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date February 17, 2005
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K050117.
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · Blackstone Medical, Inc. · May 2005
ABC 2 SCREW
K050813 · Aesculap, Inc. · May 2005
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
K050804 · Aesculap, Inc. · Apr 2005
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066 · Pioneer Surgical Technology · Feb 2005
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
K031782 · Medtronic Sofamor Danek · Feb 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151 · Medtronic Sofamor Danek · Feb 2005