4CIS VANE SPINE SYSTEM

K121615 · Solco Biomedical Co., Ltd. · MNI · Aug 15, 2012 · Orthopedic

Device Facts

• Record ID: K121615
• Device Name: 4CIS VANE SPINE SYSTEM
• Applicant: Solco Biomedical Co., Ltd.
• Product Code: MNI · Orthopedic
• Decision Date: Aug 15, 2012
• Decision: SESE
• Submission Type: Special
• 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

The 4CIS® VANE Spine System is a top-loading, posterior spinal fixation system; components include pedicle screws, rods, nuts, and transverse linking mechanisms. Surgeons use the system to build spinal implant constructs to stabilize and promote fusion in the lumbosacral spine. The device is used in an operating room setting by orthopedic or neurosurgeons. The system is non-sterile, single-use, and requires specialized instruments for application and removal. By providing rigid fixation, the device stabilizes the vertebral column, facilitating bone fusion and potentially reducing patient pain and neurological symptoms associated with spinal instability or deformity.

Clinical Evidence

Bench testing only. Biomechanical strength was evaluated using static and dynamic compression and static torsion testing per ASTM F1717 to demonstrate equivalence to predicate devices.

Technological Characteristics

System consists of pedicle screws, rods, nuts, and cross-links. Fabricated from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. Top-loading, polyaxial, and poly-reduction design. Non-sterile, single-use. No software or electronic components.

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 fusion after 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

• Global Spinal Fixation System (K001668)
• OPTIMAM, Spinal System (K031585)
• 4CIS® VANE Spine System (K101818)

Submission Summary (Full Text)

{0}------------------------------------------------

# K121615

## 510(k) SUMMARY

# AUG 15 2012

1 1 1 6

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

#### Submission Information

| Contact: | Seayoung Ahn | | |
|----------------|------------------------------------------------------|--|--|
| | 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 | | |
| Date Prepared: | March 14, 2006 | | |
| | | | |

## 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 |

#### Reason for this Submission

Poly axial and poly reduction screw sizes in diameter 8.0mm and length 20mm ~80 mm are added to the existing sizes.

# Substantially Equivalent Predicate Legally Marketed Devices

The subject devices, 4CIS® VANE Spine System is substantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation System(K001668) and OPTIMAM, Spinal System(K031585), 4CIS® VANE Spine System(K101818)

## 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

Solco_Biomedical Co.,Ltd

4CIS® VANE Spine System 510(k) Submission

{1}------------------------------------------------

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 implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System

#### 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, spinal tumor, 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

This is submitted as a Special 510k because these do not create any worst case at all in the testing (static and dynamic compression, static torsion testing per ASTM F1717) by considering biomechanical strength relationship.

#### Conclusion

Solco biomedical concludes that the changes to the system do not introduce any Sere risks and therefore, the system is Substantially Equivalent to the predicate device.

# Solco Biomedical Co.,Ltd

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

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

Solco Biomedical Company Limited % Solco USA. Incorporated Saeyoung Ahn 9700 Great Seneca Highway, Suite 302 Rockville, Maryland 20850

Re: K121615

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: July 19, 2012 Received: July 20, 2012

Dear Saeyoung 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 r ou may anterest 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

AUG 15 2012

{3}------------------------------------------------

## Page 2 - Saeyoung Ahn

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/Resourcesfor You/Industry/default.htm.

Sincerely vours

Sincerely, yours,

for Dhik ner. On
Mark N. Melkerson

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

Enclosure

{4}------------------------------------------------

## Indications for Use Statement

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 _____________________________________________________________________________________________________________________________________________________________ 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) | | | |
|--------------------------------------------------------|--|--|--|
| | | | |

(Division Sign-Off)

Dision of Surgical Orthopedic, and Restorative De less

KIZIKIS 510(k) Number_

Solco Biomedical Co.,Ltd

4CIS® VANE Spine System 510(k) Submission