Cleared Traditional

Zenius™, lliad™ and Kora™ Spinal Fixation Systems (K171526) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171526 · Medyssey USA, Inc. · Orthopedic device
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Aug 2017
Decision
88d
Days
Class 2
Risk

K171526 is an FDA 510(k) clearance for the Zenius™, lliad™ 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 21, 2017 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 USA, Inc. devices

Submission Details

510(k) Number K171526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2017
Decision Date August 21, 2017
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.

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 Peers - NKB Thoracolumbosacral Pedicle Screw System

All 448
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K171526.
NuVasive® Precept™ Spinal System
K171894 · Nu Vasive, Incorporated · Sep 2017
Range/Denali/Mesa Spinal System
K171832 · K2m, Inc. · Sep 2017
Additional VIPER PRIME™ screws with fenestrations
K171570 · Medos International SARL · Aug 2017
M.U.S.T. Combined Set Screws
K171758 · Medacta International S.A. · Aug 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
K171170 · Medacta International S.A. · May 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496 · Stryker Corporation · May 2017