Cleared Traditional

K140564 - BN LUMBAR CAGE SYSTEM

K140564 is an FDA 510(k) clearance for BN LUMBAR CAGE SYSTEM, manufactured by Medyssey USA, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K140564 · Medyssey USA, Inc. · Orthopedic device
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Jun 2014
Decision
92d
Days
Class 2
Risk

K140564 is an FDA 510(k) clearance for the BN LUMBAR 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 USA, Inc. (Fr. Myers, US). The FDA issued a Cleared decision on June 5, 2014 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medyssey USA, Inc. devices

FDA 510(k) Submission Details - K140564

510(k) Number K140564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2014
Decision Date June 05, 2014
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 644
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K140564.
ALTERA SPACER
K140411 · Globus Medical, Inc. · Jul 2014
COROENT THORACOLUMBAR IMPLANTS
K140659 · Nu Vasive, Incorporated · Jun 2014
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
K140759 · Medos International SARL · Jun 2014
SKYHAWK INTERBODY FUSION SYSTEM
K140709 · Orthofix, Inc. · May 2014
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · Seaspine, Inc. · May 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · Exactech, Inc. · Apr 2014