4CIS VANE SPINE SYSTEM

K101818 · Solco Biomedical Co., Ltd. · MNH · Feb 11, 2011 · Orthopedic

Device Facts

• Record ID: K101818
• Device Name: 4CIS VANE SPINE SYSTEM
• Applicant: Solco Biomedical Co., Ltd.
• Product Code: MNH · Orthopedic
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 4CIS VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

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 to stabilize and promote fusion in the lumbosacral spine. Implants are fabricated from titanium alloy (Ti-6Al-4V ELI). System requires specialized instruments for application and removal. Provides mechanical stabilization to the spine; intended for removal after solid fusion is achieved. Benefits patients by addressing spinal instability and deformity.

Clinical Evidence

Bench testing only. Mechanical testing conducted in accordance with ASTM F1717 to evaluate static and dynamic compression and static torsion, demonstrating equivalence to predicate devices.

Technological Characteristics

Posterior non-cervical pedicle screw system. Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. Components: Pedicle screws, rods, nuts, transverse linking mechanism. Mechanical testing performed per ASTM F1717. Supplied non-sterile; single-use.

Indications for Use

Indicated for skeletally mature patients with degenerative spondylolisthesis (Grade 3-4) with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, or pseudarthrosis of the lumbosacral spine requiring non-cervical posterior pedicle screw fixation as an adjunct to fusion, following at least 6 months of failed non-operative treatment.

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

• Optima (K031585)
• 4CIS Vane Spine Systems (K060702)
• 4CIS Vane Spine Systems (K081145)

Submission Summary (Full Text)

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FEB 1 1 2011

## 510(k) SUMMARY

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

#### Submission Information

| Contact: | Seayoung Ahn; [e-mail] |
|----------------|------------------------------------------------------|
| | 9700 Great Seneca Hwy, Sweet 302, Rockville, MD20850 |
| Sponsor: | Solco Biomedical Co., Ltd. |
| | 34-6 Keumam-ri, Seotan-myeon, |
| | Pyeongtaek, Gyeonggi-do, 451-852 |
| | Republic of Korea; Tel: [phone] |
| Date Prepared: | March 14, 2006(original), and February 08, 2011 |

#### Device Identification

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

#### Substantially Equivalent Predicate Legally Marketed Devices

Functional and mechanical testing such as static and dynamic compression testing and static torsion testing were used to demonstrate the comparable mechanical & functional properties of the subject 4CIS VANE Spine System to the predicate devices (Optima K031585; 4CIS Vane Spine Systems cleared earlier under K060702 & K081145) to support a determination of substantial equivalence.

### Device Description

The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism. The 4CIS® VANE Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® VANE Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System.

Solco Biomedical Co.,Ltd

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## Indications for Use

The 4CIS VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

#### Performance Data

Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the predicate devices provided in Appendix 8..

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Solco Biomedical Co., Ltd. % Dr. Saeyoung Ahn 9700 Great Seneca Highway, Suite 302 Rockville, Maryland 20850

Re: K101818

Trade/Device Name: 4CIS® VANE Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH. MNI Dated: January 11, 2011 Received: January 14, 2011

Dear Dr. Ahn:

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

FEB 1 1 201

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Page 2 - Dr. Saeyoung Ahn

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/CDRH0ffices/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

For Peter Thomas

Mark N. Melkerson

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

Enclosure

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# Indications for Use Statement

K101818 510(k) Number (if known):

4CIS® VANE Spine System Device Name:

Indications for Use:

The 4CIS VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

(Division Si, Off) Division of Servical, Orthopedic, and Restorative Devices

KIO1818 510(k) Number_

Solco Biomedical Co.,Ltd

4CIS® VANE Spine System 510(k) Submission