Cleared Special

Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (K181978) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181978 · Medyssey USA, Inc. · Orthopedic device
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Aug 2018
Decision
20d
Days
Class 2
Risk

K181978 is an FDA 510(k) clearance for the Zenius™, Iliad™ and Kora™ Spinal Fixation Systems. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medyssey USA, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on August 13, 2018 after a review of 20 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 USA, Inc. devices

Submission Details

510(k) Number K181978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2018
Decision Date August 13, 2018
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 Consultant

Musculoskeletal Clinical Reulatory Advisers, LLC
Margeaux Rogers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K181978.
MOSS VRS Spinal System
K181821 · Biedermann Motech GmbH & Co. KG · Sep 2018
CD HORIZON™ Spinal System
K182119 · Medtronic Sofamor Danek USA, Inc. · Aug 2018
Firebird® Spinal Fixation Systems: Firebird System
K180179 · Orthofix, Inc. · Aug 2018
Redi-Spine
K181584 · Innovative Surgical Designs, Inc. · Aug 2018
Kodiak Spinal Fixation System
K181677 · Alphatec Spine, Inc. · Aug 2018
Stowe Pedicle Screw System
K181554 · Black Box Medical · Jul 2018