4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

K050471 · Solco Biomedical Co., Ltd. · MNH · May 12, 2005 · Orthopedic

Device Facts

• Record ID: K050471
• Device Name: 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
• Applicant: Solco Biomedical Co., Ltd.
• Product Code: MNH · Orthopedic
• Decision Date: May 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are 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: degenerative Spondylolisthesis with objective evidence of neurological 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, nuts, and transverse linking mechanism. Used by surgeons in clinical settings to build spinal implant constructs; stabilizes segments to promote fusion. Fabricated from titanium alloy; supplied non-sterile; single-use. Specialized instruments provided for application and removal. Implants attached to thoracic, lumbar, and sacral spine; removed after solid fusion attainment. Provides immobilization and stabilization for various spinal pathologies.

Clinical Evidence

Bench testing only. Mechanical testing conducted in accordance with ASTM F1717 to demonstrate equivalence to predicate devices.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. Top-loading posterior spinal fixation system including pedicle screws, rods, nuts, and transverse linking mechanism. Non-sterile, single-use. Mechanical performance validated per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe Spondylolisthesis (Grade 3-4) at L5-S1, or as an adjunct to fusion for thoracic, lumbar, and sacral instabilities/deformities including degenerative Spondylolisthesis with neurological 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

• Global Spinal Fixation System (K001668)
• OPTIMA™, Spinal System (K031585)

Submission Summary (Full Text)

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K050471.

# MAY 1 2 2005 510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

### Submission Information

| Contact: | Seayoung Ahn |
|----------------|--------------------------------------|
| | 7612 Barnum Road, Bethesda, MD 20817 |
| Sponsor: | 34-6 Keumam-ri, Seotan-myeon, |
| | Pyeongtaek, Gyeonggi-do, 451-852 |
| | Republic of Korea |
| Date Prepared: | February 21, 2004 |

### Device Identification

| Trade Name: | 4CIS® SOLAR Spine System and<br>4CIS® APOLLON Spine System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Pedicle Screw Spinal Fixation System |
| Classification Name: | Spondylolisthesis Spinal Fixation Device System(MNH)<br>per 21 CFR § 888.3070,<br>Spinal Pedicle Screw(MNI) per 21 CFR § 888.3070 |

### Substantially Equivalent Predicate Legally Marketed Devices

The subject devices, 4CIS SOLAR Spine System and 4CIS® APOLLON Spine System, are substantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation System(K001668) and OPTIMA™, Spinal System(K031585)

### Device Description

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these

### Solco Biomedical Co.,Ltd

4CIS" SOLAR Spine System and 4CIS" APOLLON Spine System 510(k) Submission

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implants are available. Specialized instruments are available for the application and removal of the 4C1S * SOLAR Spine System and 4CIS * APOLLON Spine System.

### Indications for Use

The 4CIS * SOLAR Spine System and 4CIS * APOLLON Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the 4CIS SOLAR Spine System and 4CIS * APOLLON Spine System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

### Performance Data

Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three parallel lines that curve upwards, resembling a bird in flight, with a wavy line beneath them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2005

Solco Biomedical c/o Dr. Saeyoung Ahn 7612 Barnum Road Bethesda, Maryland 20817

Re: K050471

KU50471
Trade/Device Name: 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System Regulation Number: 888.3070(b)(1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNH, MNI Dated: February 22, 2005 Received: February 23, 2005

Dear Mr. Ahn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave ustermined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regard cate of the Medical Device Amendments, or to commerce prof to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, therefore, market the devices, boyer is annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it i If your device is classified (500 above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar Ing your device in the Federal Register.

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## Page 2 – Dr. Saeyoung Ahn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substantial with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a determination that your ac-res by other Federal agencies. You must or any Federal statutes and regulations acminities or registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, monama, considerents as set
CFR Part 807); labeling (21 CFR Part 801); good if caplicable, the electronic CFR Part 807); labeling (21 CFR Fart 801); good manarat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 640); 14 CFP 1000-105 forth in the quality systems (Q5) regaliation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections 997 - 12 certibed in your Section 510(k)
This letter will allow you to begin marketing your device as described in your device I his letter will anow you to ocgainmantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your device premarket notification. The FDA inding of substantial equice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and the responsible of the could on the regulation water the rogulation e If you desire specific advice for your ac nee on on on on on one mote the regulation entitled,
contact the Office of Compliance at [phone]. ↑ Also, please note the reg contact the Office of Comphalice at (216) 276 - 76 - 76 - 16 - 16 - 16 - 10 - 10 - Division of Small "Misbranding by reference to premation iountiedation" (= " = other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance of Circustomers/spancer/index.htm Manufacturers, International and Consumer Plastianter Province Portions of Support/index.html.

Sincerely yours,

Stupt Rurda

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

KOSO471

Device Name: 4C15® SOLAR Spine System and 4CIS® APOLLON Spine System

Indications for Use:

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertehra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypt Rhodes

Division of General. Restorative. and Neurological Devices

KOSD471 510(k) Number_

Solco Biomedical Co.,Ltd