ZENIUS SPINAL SYSTEM

K103272 · Medyssey Co, Ltd. · MNI · Dec 29, 2010 · Orthopedic

Device Facts

• Record ID: K103272
• Device Name: ZENIUS SPINAL SYSTEM
• Applicant: Medyssey Co, Ltd.
• Product Code: MNI · Orthopedic
• Decision Date: Dec 29, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).

Device Story

Top-loading posterior spinal fixation system; components include pedicle screws, rods, set screws, and transverse linking mechanism. Used for immobilization and stabilization of spinal segments as adjunct to fusion. Implanted by surgeons in clinical settings. System provides mechanical support to spine during fusion process; implants intended for removal after solid fusion attainment. Operates via mechanical fixation of spinal segments using titanium alloy hardware.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) per ASTM F 136. Top-loading posterior spinal fixation system. Components: pedicle screws, rods, set screws, transverse linking mechanism. Surgical instrument grade stainless steel tools. Mechanical fixation principle.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion with autogenous bone graft for treatment of thoracic, lumbar, and sacral spine instabilities or deformities, including severe spondylolisthesis (grades 3-4, L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis.

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

• Zenius Spinal System (K093104)

Submission Summary (Full Text)

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C103272

lase (of2

DEC 2 9 2010

## 510(k) SUMMARY

"Special 510 (K): Device Modification" Premarket Notification: Zenius "M Spinal System

# 1. Submitter/Sponsor:

Medyssev Co. Ltd. Patrick D. Moore, Official US Correspondent 722-3, 4F. Science Tower, Jihaeng-dong, Dongducheon-city, Gyeonggi-do, Korea

## Contact person:

Patrick D. Moore Official US Correspondent Medyssey Co. Ltd. 6170 South 380 West, Suite 200. Murray, Utah. 84107 801-266-4811, Fax. [phone]; E-Mail: [e-mail] Tel.

## Date Prepared:

December 7th, 2010

# 2. Device Name:

| Classification Name: | Pedicle Screw Spinal Fixation System |
|----------------------|-------------------------------------------|
| Common/Generic Name: | Pedicle Screw Spinal System |
| Trade Name: | Medyssey Co., Ltd. ZeniusTM Spinal System |

# 3. Device Classification(s):

Class II (88.3390) following Orthopedic and Rehabilitation Device Advisory Review, for the requested indications:

- Spinal Pedicle Screw (MNI) 21 CFR § 888.3070 ●
- Spondylolisthesis Spinal Fixation Device System (MNH) 21 CFR § . 888.3070
- Spinal Intervertebral Body Fixation Orthosis (KWQ) 21 CFR § 888.3060 .

# 4. Predicate Device:

Medyssey Co., Ltd., Zenius" Spinal System -- MNI, MNH, KWQ -- (K093104)

# 5. Device Description:

The Zenius "M Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross)
linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius™ Spinal System implants.

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0103272 ge 2 of 2

#### 6. Intended Use:

The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal seqments 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; deqenerative spondvlolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

7. Comparison with predicate device: The Modified Zenius™ Spinal System is substantially equivalent to the currently marketed Zenius™ Spinal System. When considered for anterior applications, both the Modified Zenius™ Spinal System and the Zenius™ Spinal System worst case constructs consist of the same universal housing containing the same pre-assembled pedicle screw and set screw. Both systems use the same vertical rods which are both placed into the housing. The same set screws are subsequently tightened onto the rod. providing a completed implant assembly.

The principles of operation for the subject Zenius™ Spinal System device, and the cited predicate technologies are same. That is, each of these products employs the same indications for use, contraindications for use, warnings and precautions within labeling. The principles of operation of the subject device are directly equivalent to those of the cited predicates cleared by the Agency and currently being marketed.

The design and development process of the manufacturer of subject system and Predicate system conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems.

The subject and predicate device was evaluated/tested per established requirements.

The predicate device underwent mechanical testing included Static Compression Bending; Static Tension Bending; and Static Torsional Testing; Dynamic Compression Bending tests were also conducted. All testing performed per ASTM F 1717-04. The subject device contains dimensionally modified components (not worst case) and therefore not subject to ASTM F 1717-04 additional testing.

Clinical tests: No clinical tests conducted on either the subject system nor the predicate svstem.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

DEC 29 : ..

Medyssey Co., Ltd. % Mr. Patrick D. Moore 6170 South 380 West, Suite 200 Murray, Utah 84107

Re: K103272

Trade/Device Name: Medyssey Co., Ltd. Zenius™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWO Dated: December 07, 2010 Received: December 20, 2010

Dear Mr. Moore:

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

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#### Page 2 - Mr. Patrick D. Moore

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

for O

Mark N Melker Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number (if known): K103272

Device Name: Medyssey Co., Ltd. Zenius™ Spinal System

Indications for Use: The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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#### Concurrence of CDRH. Office of Device Evaluation (ODE)

Sul Lin for Ronald Jean
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103272

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