4CIS PEEK, PLIF AND TLIF CAGE SYSTEM

K092162 · Solco Biomedical Co., Ltd. · MAX · Jan 6, 2010 · Orthopedic

Device Facts

• Record ID: K092162
• Device Name: 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
• Applicant: Solco Biomedical Co., Ltd.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 4CIS® PEEK PLIF is intervertebral body fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 4CIS® PEEK PLIF ™ IBF device is intended to be used with autologous bone graft to facilitate fusion. The 4CIS® PEEK PLIF ™ IBF device is to be used in patients, who have had six months of non-operative treatment. The device is to be implanted via a direct posterior approach. The 4CIS® PEEK PLIF ™ device may be implanted singly or in pairs in the lumbosacral spine with supplemental fixation.

Device Story

The 4CIS PEEK PLIF Cage System is an intervertebral body fusion device designed for lumbar spinal stabilization. The device features a PEEK-OPTIMA LT1 body with vertical teeth to enhance anchoring and prevent migration or subsidence into the vertebral endplate. It includes two tantalum markers for radiographic visualization. The device is implanted by a surgeon via a direct posterior approach, either singly or in pairs, and must be used in conjunction with supplemental spinal fixation and autologous bone graft. It serves to facilitate spinal fusion in patients with degenerative disc disease, aiming to reduce discogenic back pain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: PEEK-OPTIMA LT1 (ASTM F2026). Features: Vertical teeth for anchoring, tantalum markers for radiopacity. Form factor: Intervertebral cage for PLIF. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one or two contiguous levels (L2-S1) who have failed six months of non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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

KO42.162

JAN - 62010

## 510(k) SUMMARY

The following 510(k) summary is being submitted as required by

| Submission Information | |
|------------------------|-------------------------------------------------------|
| Contact: | Seayoung Ahn |
| | 155 Gibbs Street Suite 510 Rockville, MD 20850 |
| | [e-mail] [phone](o); [phone] |
| Sponsor: | 34-6 Keumam-ri, Seotan-myeon, |
| | Pyeongtaek, Gyeonggi-do, 451-852 |
| | Republic of Korea |
| Date Prepared: | May 5, 2009 |
| Device Identification | |
| Trade Name: | 4CIS® PEEK PLIF Cage System |
| Common/Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device - lumbar |
| | 21 CFR Section 888.3080 |
| | MAX |
| | Class II |

Substantially Equivalent Predicate Legally Marketed Devices

### Device Description

The subject device, 4CIS® PEEK PLIF Cage System is made of devices for fixation of spine. This system allows maximum preservation of bony endplate and vertical square teeth ensure enough contact surfaces with bony endplate, which prevents "sinking-in" of cage into the vertebral body, while vertical teeth increase the anchoring and prevent slipping. It has two tantalum markers for ease of visualization on radiographs.

The components are manufactured from PEEK-OPTMA LT1 (Polyetheretherketone, ASTM F2026) material.

### Indications for Use

The 4CIS PEEK PLIF IBF Device is an intervertebral body device intended for use skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic pack pain with degeneration of the disk confirmed by history and radiographic studies. 4CIS Peek PLIF IBF devices are intended to be used with autologous bone graft to facilitate fusion. The device is to be used in patients who have had six months of non-operative treatment.

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

The 4CIS PEEK PLIF IBF devices are to be implanted via a direct posterior approach. The device is implanted singly or in pairs, with supplemental fixation.

:

.

# Performance Data

Mechanical testing as listed in APPENDIX 10

70

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

#### Public Health Service

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

# JAN - 62010

Solco Biomedical Co., Ltd. % Solco USA, Inc. Mr. Saeyoung Ahn Official Correspondent 155 Gibbs Street, Suite 510 Rockville, Maryland 20850

Re: K092162

Trade/Device Name: 4CIS® PEEK PLIF Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MAX Dated: December 23, 2009 Received: December 24, 2009

Dear Mr. 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. Insting of devices, good manufacturing practice, 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 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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

Page 2 - Mr. Saeyoung Ahn

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Milliken

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

## 510(k) Number (if known): __ K092162

4CIS PEEK PLIF Cage System Device Name:

Indications For Use:

The 4CIS® PEEK PLIF is intervertebral body fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 4CIS® PEEK PLIF ™ IBF device is intended to be used with autologous bone graft to facilitate fusion. The 4CIS® PEEK PLIF ™ IBF device is to be used in patients, who have had six months of non-operative treatment. The device is to be implanted via a direct posterior approach. The 4CIS® PEEK PLIF ™ device may be implanted singly or in pairs in the lumbosacral spine with supplemental fixation.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division/Sign-Off) | | Page 1 of | |
|-----------------------------------|--|-----------|--|
| Division of Surgical, Orthopedic, | | | |
| and Restorative Devices | | | |

| 510(k) Number | K092162 |
|---------------|---------|
|---------------|---------|