Cleared Special

K103272 - ZENIUS SPINAL SYSTEM

K103272 is an FDA 510(k) clearance for ZENIUS SPINAL SYSTEM, manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 54-day FDA review.

K103272 · Medyssey Co, Ltd. · Orthopedic device
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Dec 2010
Decision
54d
Days
Class 2
Risk

K103272 is an FDA 510(k) clearance for the ZENIUS SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medyssey Co, Ltd. (Murray, US). The FDA issued a Cleared decision on December 29, 2010 after a review of 54 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.

View all Medyssey Co, Ltd. devices

FDA 510(k) Submission Details - K103272

510(k) Number K103272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2010
Decision Date December 29, 2010
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 290
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K103272.
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011
LEUCADIA PEDICLE SCREW SYSTEM
K103102 · Phygen, LLC · Feb 2011
TALON SPINAL SYSTEM
K102995 · Spine360 · Feb 2011
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K103147 · Medyssey Co, Ltd. · Dec 2010
S 100 PEDICLE SCREW SYSTEM
K101682 · Renovis Surgical Technologies, LLC · Dec 2010
MOUNTAINEER OCT SPINAL SYSTEM
K103100 · Depuy Spine, Inc. · Nov 2010