VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

K121096 · L&K BIOMED Co., Ltd. · MAX · Jul 6, 2012 · Orthopedic

Device Facts

• Record ID: K121096
• Device Name: VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Device Story

VENUS Lumbar Intervertebral body Fusion Cage System is an intervertebral fusion device designed to provide support in the intervertebral body space during lumbar spine fusion. The system consists of implants available in various heights and lordotic configurations featuring an open architecture to accommodate autogenous bone graft material. It is intended for use in conjunction with supplemental fixation. The device is implanted by a surgeon during intervertebral body fusion procedures. By maintaining disc space height and facilitating fusion, the device aims to alleviate discogenic back pain associated with degenerative disc disease. The system is a mechanical implant and does not involve electronic processing or software.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Implants constructed from PEEK-OPTIMA LTI with Titanium alloy (Ti-6Al-4V ELI) marker pins. Open architecture design for bone graft packing. Available in various heights and lordotic configurations. Mechanical device; no energy source or software.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of prior nonoperative 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.

Predicate Devices

• VENUS Lumbar Intervertebral Body Fusion Cage System (K110783, K120063)
• Any Plus PEEK Cage (K100516)
• AVS PEEK Spacer System (K083661, K090816, K093704)
• 4CIS PEEK PLIF Cage System (K092162)
• NuVasive CoRoent System (K043405, K052210, K071795, K081611)
• JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720)
• CLYDESDALE Spinal System (K100175, K112405, K113528)

Submission Summary (Full Text)

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

VENUS Lumbar Intervertebral body Fusion Cage System

6 2012 JUL

# 510(k) SUMMARY

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

- 1. Purpose
2.

The purpose of this submission is to add additional device sizes to the model PLIF, TLIF, ALIF and DLIF devices.

Submitter: L&K BIOMED Co., Ltd. #1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong, Geumicheon-gu, Seoul 153-803 Republic of Korea Contact Person: Kihyang Kim Phone. [phone] FAX .[phone] E-mail: [e-mail] Date Prepared April 9, 2012

3. Device Identification

| Trade Name | VENUS Lumbar Intervertebral body Fusion Cage System |
|-------------------|-----------------------------------------------------|
| Common/Usual Name | Intervertebral Fusion Device |
| Regulation Name | Intervertebral body fusion device (21 CFR 888.3080) |
| Regulatory Class | Class II |
| Product Code | MAX |

#### 4. Description of the Device

The VENUS Lumbar Intervertebral body Fusion Cage System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The VENUS Lumbar Intervertebral body Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA® LTI body with the titanium marker pins made of Titanium alloy (Ti-6Al-4V ELI). The purpose of this submission is to add the size of the devices.

#### 5. Indications for Use

VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System

Special 510(K)

Page 30/ 92

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

VENUS Lumbar Intervertebral body Fusion Cage System

is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

### 6. Non-clinical Testing

The proposed line extension for the VENUS Lumbar Intervertebral body Fusion Cage System does not constitute a new worst case for the intended use and is substantially equivalent to the predicate device (K110783, K120063),

#### 7. Summary of technology characteristics

The VENUS Lumbar Intervertebral body Fusion Cage System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials and the same intended use.

## 8. Predicate or legally marketed devices which are substantially equivalent

The design feature and indications for the subject VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the following predicates:

- ••• L&K BIOMED: VENUS Lumbar Intervertebral Body Fusion Cage System (K110783, K120063)
- ··· GS Medical: Any Plus PEEK Cage (K 100516)
- ··· STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704)
- ··· Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162)
- ··· Nuvasive: NuVasive CoRoent System (K043405,K052210 K071795, K081611)
- ··· Spine Art : JULIET OL , DYNAMIK Intervertebral body fusion device (K081888, K101720)
- ··· Medtronic Sofamor Danek: CLYDESDALE Spinal System (K100175,K112405,K113528)

### 9. Conclusion

The VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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

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 caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement. The text is in all caps and is written in a sans-serif font.

JUL

6 2012

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

L&K BIOMED Co., Ltd. % Kihyang Kim #1104, Ace High-end Tower 3 cha 371-50, Gasan-Dong, Geumcheon-gu Seoul 153-803 Republic of Korea

Re: K121096

Trade/Device Name: VENUS Lumbar Intervertebral body Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, Dated: June 6, 2012 Received: June 6, 201

Dear Kihyang Kim:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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

### Page 2 - Kihyang Kim

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 yours.

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 : K121096

Device Name : VENUS Lumbar Intervertebral body Fusion Cage System

Indications for Use :

VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

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)

Antoz

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion Sien-Oil) (Div/ Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K121096
Special 510(K)