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The Medyssey Co, Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The IliadTM Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

The KoraTM Spinal Fixation and Adjustable Bridge System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

The Zenius™ Spinal System, Internal Fixation Device for Spinal Surgery is comprised of: Rods, Pedicle Screw Assemblies, Compression Retaining Assemblies, and Transverse-Link Assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

For all three systems, components are manufactured from Ti6Al4V ELI per ASTM F136 and wrought Co-Cr-Mo alloy per ASTM F1537.

The provided text describes a 510(k) Pre-market Notification for a medical device, specifically pedicle screw systems. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

Instead, the document focuses on:

• Device Identification: Trade names, product class, classification, common name, and product codes.
• Purpose of Submission: To add new component sizes and update indications for use to align with Class III device standards.
• Indications for Use: Detailed list of conditions for which the spinal systems are intended.
• Device Descriptions: Composition and materials of the Iliad, Kora, and Zenius Spinal Systems.
• Predicate Devices: Stating substantial equivalence to previously cleared Medyssey pedicle screw systems.
• Performance Standards: A statement that no new performance testing was necessary because the additional components don't represent a new worst-case scenario, and previous static and dynamic testing on predicate devices was sufficient.
• Conclusion: The pedicle screw systems are substantially equivalent and raise no new safety or effectiveness concerns.
• FDA Response: An acknowledgement of the 510(k) submission and determination of substantial equivalence.

Therefore, I cannot provide the requested information as it is not present in the given text. The document explicitly states: "The additional components being added in this submission do not represent a new worst case. Therefore, no new performance testing is necessary to justify their substantial equivalence. Static and dynamic compression bending, static torsion and per ASTM F1717 was performed on the predicate worst constructs and presented in the predicate submissions." This indicates that no new study was conducted for this specific submission to prove new acceptance criteria or performance.

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