Cleared Special

K121246 - MEDYSSY LT CAGE SYSTEM

K121246 is an FDA 510(k) clearance for MEDYSSY LT CAGE SYSTEM, manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 51-day FDA review.

K121246 · Medyssey Co, Ltd. · Orthopedic device
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Jun 2012
Decision
51d
Days
Class 2
Risk

K121246 is an FDA 510(k) clearance for the MEDYSSY LT CAGE 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 Medyssey Co, Ltd. (Skokie, US). The FDA issued a Cleared decision on June 15, 2012 after a review of 51 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 Medyssey Co, Ltd. devices

FDA 510(k) Submission Details - K121246

510(k) Number K121246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2012
Decision Date June 15, 2012
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 649
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K121246.
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121096 · L & K Biomed Co., Ltd. · Jul 2012
DEPUY PULSE LUMBAR CAGE SYSTEM
K120966 · Medos International SARL · Jul 2012
NUVASIVE COROENT TITANIUM SYSTEM
K120918 · Nuvasive, Inc. · Jun 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K121129 · Spineology, Inc. · Jun 2012
LUCENT OR LUCENT MAGNUM
K110632 · Spinal Elements, Inc. · May 2012
PLATEAU SPACER SYSTEM
K121116 · Life Spine · May 2012