Iliad® Pedicle Screw System and Zenius® Pedicle Screw System

K171509 · Medyssey USA, Inc. · NKB · Jun 12, 2017 · Orthopedic

Device Facts

• Record ID: K171509
• Device Name: Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
• Applicant: Medyssey USA, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Jun 12, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Iliad and Zenius Spinal Systems are internal fixation devices for spinal surgery; comprised of rods, pedicle screw assemblies, compression retaining assemblies, and transverse-link assemblies. This submission adds hook-type rod connectors to existing systems. Devices are used by surgeons in clinical settings to provide posterior, noncervical pedicle fixation as an adjunct to spinal fusion. Implants are adapted to patient-specific pathology. Mechanical stability is provided through the assembly of components, supporting the fusion process and potentially alleviating symptoms associated with spinal conditions.

Clinical Evidence

Bench testing only. Axial grip testing was performed per ASTM F1798-13 to demonstrate mechanical equivalence to the predicate devices.

Technological Characteristics

System components include rods, pedicle screws, compression retaining assemblies, and transverse-link assemblies. Rod connectors are manufactured from Ti6Al4V ELI per ASTM F136. Mechanical performance validated via axial grip testing per ASTM F1798-13.

Indications for Use

Indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients with DDD, spondylolisthesis, trauma, spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medyssey: Iliad Pedicle Screw System and Zenius Pedicle Screw System-K142835 (K142835)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2017

Medyssey USA, Inc. % Kim Strohkirch. MS. MEM Executive Vice President MRC-X. LLC 6075 Poplar Ave Memphis. TN 38119

Re: K171509

Trade/Device Name: Iliad® Pedicle Screw System and Zenius® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: May 22, 2017 Received: May 23, 2017

Dear Ms. Strohkirch:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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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)

K171509

Device Name

Illiad® Pedicle Screw System and Zenius® Pedicle Screw System

Indications for Use (Describe)

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary - Special Iliad® and Zenius® Spinal Systems

May 22, 2017

| Company: | Medyssey USA, Inc.<br>1550 East Higgins Road, Suite 123,<br>Elk Grove Village, IL 60007<br>U.S.A.<br>Tel: [phone]<br>FAX: [phone] |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Kim Strohkirch<br>Phone: [phone] |
| Company Contact: | Shawn Kim, Director<br>Medyssey USA |
| Trade Name: | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System |
| Common Name: | Pedicle Screw System |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3070 (Thoracolumbosacral Pedicle Screw System) |
| Panel: | 87- Orthopedic |
| Product Code: | NKB |

## Predicate Devices:

Primary Predicate Device:

- . Medyssey: Iliad Pedicle Screw System and Zenius Pedicle Screw System-K142835 (Cleared 6/12/2015)
# Device Description:

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 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

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sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients.

Subject rod connectors are manufactured from Ti6Al4V ELI per ASTM F136. The subject of this submission is the addition of hook type rod connectors to the Iliad™ and Zenius™ Systems.

#### Indications for Use:

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

#### Substantial Equivalence:

The subject cannulated screws are substantially equivalent to the screws cleared in the following 510(k)s for the Iliad™ and Zenius™ Systems with respect to indications for use, dimension, and materials. The subject connectors differ from the predicate connector in design. The subject connectors are open; predicate connectors are closed. Mechanical testing demonstrates that the subject device is substantially equivalent to the predicate device.

Primary Predicate Device:

- . Medyssey: Iliad Pedicle Screw System and Zenius Pedicle Screw System-K142835 (Cleared 6/12/2015)
## Performance Testing:

Axial grip testing was performed per ASTM F1798-13 to establish that the mechanical properties of the subject devices are equivalent to the predicate devices.