Cleared Traditional

K110067 - LP CAGE

K110067 is an FDA 510(k) clearance for LP CAGE, manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K110067 · Medyssey Co, Ltd. · Orthopedic device
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Apr 2011
Decision
88d
Days
Class 2
Risk

K110067 is an FDA 510(k) clearance for the LP CAGE. 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. (Apple Valley, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medyssey Co, Ltd. devices

FDA 510(k) Submission Details - K110067

510(k) Number K110067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2011
Decision Date April 08, 2011
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 651
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K110067.
MECTALIF
K110927 · Medacta International · Jun 2011
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K110933 · Spineology, Inc. · Jun 2011
SEASPINE SPACER SYSTEM
K102026 · Seaspine, Inc. · May 2011
FORZA SPACER SYSTEM
K103111 · Orthofix, Inc. · Mar 2011
LANX LATERAL
K103666 · Lanx, Inc. · Mar 2011
PEZO INTERBODY CAGES SYSTEM
K103814 · Ulrich GmbH & Co. KG · Mar 2011