The Medyssey Co, Ltd. Zenius™, Iliad™ and Kora™ Spinal Fixation Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft 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, kyphosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

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 account for the unique pathology of individual patients.

The Iliad™ 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 Kora™ 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 subject of this 510(k) is the addition of Z-Rods to the spinal systems.

AI/ML Overview

The provided document describes the Medyssey USA, Inc. Zenius™, Iliad™ and Kora™ Spinal Fixation Systems, specifically focusing on the addition of "Z-Rods" to these systems. The document is a 510(k) premarket notification summary to the FDA, indicating a request for clearance based on substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that mechanical testing was performed according to ASTM F2193-14. The acceptance criteria would be the standards set forth by this ASTM standard for spinal implant constructs. The reported device performance is that the "Results demonstrated substantial equivalence compared to the predicate device."

Test Type	Acceptance Criteria	Reported Device Performance
Mechanical	Conformance to ASTM F2193-14 standards for spinal implant constructs (implied by reference to the standard and claims of substantial equivalence)	Demonstrated substantial equivalence compared to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Mechanical testing per ASTM F2193-14 was performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is a mechanical performance study, not a clinical study involving experts or ground truth establishment in a diagnostic context. Therefore, this question is not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as this is a mechanical performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable, as this is a mechanical performance study.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

Not applicable, as this is a mechanical performance study of a physical spinal fixation system, not a software algorithm.

7. Type of Ground Truth Used:

For this mechanical performance study, the "ground truth" would be the established engineering and biomechanical properties and performance requirements outlined in the ASTM F2193-14 standard.

8. Sample Size for the Training Set:

Not applicable, as this is a mechanical performance study. There is no "training set" in the context of device mechanical testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this is a mechanical performance study.

Summary

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August 13, 2018

Medyssey USA, Inc. % Ms. Margeaux Rogers Senior Associate, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K181978

Trade/Device Name: Zenius™, Iliad™ and Kora™ Spinal Fixation Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 24, 2018 Received: July 24, 2018

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181978

Device Name

Zenius™, Iliad™ and Kora™ Spinal Fixation Systems

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K181978 Page 1 of 2

5. 510(k) Summary

Manufacturer:	Medyssey USA, Inc.1550 East Higgins Road, Suite 123Elk Grove Village, IL 60007U.S.A.
Contact:	Ms. Margeaux RogersSenior Associate, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5805Email: mrogers@mcra.com
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	July 24, 2018
Device Trade Name:	Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
Common Name:	Pedicle Screw System
Classifications:	21 CFR §888.3070 – Thoracolumbosacral pedicle screwsystemClass II
Product Codes:	NKB
Primary Predicate Device:	Zenius™, Iliad ™ and Kora™ Spinal Fixation Systems(K171526, K171509)

Indications for Use:

The Medyssey Co, Ltd. Zenius™, Iliad™ and Kora™ Spinal Fixation 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

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Device Description:

The subject of this 510(k) is the addition of Z-Rods to the spinal systems.

Performance Testing:

Mechanical testing per ASTM F2193-14 was performed in accordance with the results of the risk analysis. Results demonstrated substantial equivalence compared to the predicate device.

Substantial Equivalence:

The subject Z-Rods are substantially equivalent to the rods cleared in K171526 and K171509 for the Zenius, Iliad and Kora Spinal Fixation Systems with respect to indications for use, dimensions and materials. The subject Z-Rods are pre-bent with 90° curvature. Mechanical testing per ASTM F2193-14 demonstrates that the subject device is substantially equivalent to the predicate devices.

Conclusion:

The subject 510(k) demonstrated the Zenius, Iliad and Kora Spinal Fixation Systems with the Z-Rod are substantially equivalent to the primary predicate device.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.