Zenius, lliad and Kora Spinal Fixation Systems

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K171526 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Zenius™ Spinal System

  Class II

  FDA 510(k) K232218 Active Cleared 24 Aug 2023

• Triton Cage

  Class II

  FDA 510(k) K183407 Active Cleared 30 Aug 2019

• Medussa-PL Cage

  Class II

  FDA 510(k) K170341 Active Cleared 2 Nov 2017

• Bn Lumbar Cage System

  Class II

  FDA 510(k) K140564 Active Cleared 5 Jun 2014

• TAURUS PEEK Cage System

  Class II

  FDA 510(k) K170389 Active Cleared 14 Dec 2017

• Athena III Cervical Plate System

  Class II

  FDA 510(k) K230301 Active Cleared 7 Mar 2023

See all devices from Medyssey USA, Inc. →

• Are the Zenius, lliad, and Kora Spinal Fixation Systems designed for use in the cervical spine, or are they limited to noncervical applications?

  These systems are explicitly designed for noncervical pedicle screw fixation, meaning they are intended for the thoracolumbar spine only. The manufacturer specifies they are not approved for cervical spine procedures, so they should not be used in the neck region.

• How are the Zenius, lliad, and Kora Spinal Fixation Systems supplied, and can they be reused in surgery?

  The systems are supplied as reusable surgical implants, meaning they are intended for multiple uses in different patients after proper cleaning, sterilization, and maintenance. They are not single-use devices, so they must be processed according to established surgical instrument reprocessing protocols.

• Do the Zenius, lliad, and Kora Spinal Fixation Systems come with specific size or configuration options, and how does that help in surgery?

  Yes, the systems include varied sizes and configurations to accommodate different anatomical requirements in the thoracolumbar spine. This flexibility allows surgeons to select the appropriate hardware for patient-specific spinal alignment and fixation needs, improving stability and fit during spinal fusion procedures.

• Are there any special storage requirements for the Zenius, lliad, and Kora Spinal Fixation Systems, such as sterility or environmental conditions?

  The data does not specify sterility requirements for these reusable systems, but since they are surgical implants, they must be stored in a clean, dry environment to prevent contamination before reprocessing. After use, they must undergo proper cleaning and sterilization before reuse, following established medical device reprocessing guidelines.

• What regulatory pathway was followed for FDA clearance of these spinal fixation systems, and what does that mean for their use in clinical settings?

  The Zenius, lliad, and Kora systems received FDA 510(k) clearance (K171526) under the Traditional 510(k) pathway, meaning they were determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates they meet FDA safety and effectiveness standards for noncervical spinal fixation and can be legally marketed and used in orthopedic settings as adjuncts to spinal fusion procedures.