VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE

K110783 · L&K BIOMED Co., Ltd. · MAX · Oct 24, 2011 · Orthopedic

Device Facts

• Record ID: K110783
• Device Name: VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: MAX · Orthopedic
• Decision Date: Oct 24, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 spondylolistesis 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 non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Lumbar intervertebral body fusion cage system; provides spinal fixation aid. Implants feature open architecture for autogenous bone graft packing; available in various heights and lordotic configurations. Used in surgical procedures by physicians; requires supplemental fixation. Benefits patients with degenerative disc disease by facilitating fusion; stabilizes spinal segments.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F 2077 (static/dynamic axial compression, compression-shear, torsion, expulsion) and ASTM F 2267 (static subsidence).

Technological Characteristics

Constructed from PEEK-OPTIMA LTI with Titanium alloy (Ti-6Al-4V ELI) marker pins. Open architecture design for bone graft. Tested per ASTM F 2077 and ASTM F 2267.

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 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.

Predicate Devices

• GS Medical (K100516)
• Stryker Spine (K083661)
• Stryker Spine (K090816)
• Stryker Spine (K093704)
• Synthes (K053508)
• Synthes (K062083)
• Synthes (K072253)
• Spine Art (K081888)
• Spine Art (K101720)
• Solco Biomedical (K092162)

Submission Summary (Full Text)

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K110783

# 510(k) SUMMARY

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

| 1. | Submitter: | L&K BIOMED Co., Ltd.<br>#1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong,<br>Geumcheon-gu, Seoul 153-803 Republic of Korea<br><br>Phone. [phone]<br>FAX. [phone] |
|----|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Contact Person:

FAX .[phone] Hee Kyeong Joo

### 2. Device Identification

| Trade Name | VENUS Lumbar Intervertebral body Fusion Cage System |
|---------------------|-----------------------------------------------------|
| Common Name | Intervertebral Fusion Device |
| Classification Name | Intervertebral body fusion device (888.3080) |
| Product Code | MAX |

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

- GS Medical: K 100516 .
- . Stryker Spine : K083661,K090816,K093704
- Synthes : K053508, K062083, K072253 .
- Spine Art : K081888, K101720
- ◆ Solco Biomedical : K092162

## 4. Description of the Device

The VENUS Lumbar Intervertebral body Fusion Cage devices intended for use as an aid in spinal 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).

Traditional 510(K)

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K110783

#### 5. 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 spondylolistesis 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 non-operative treatment prior to treatment with an intervertebral cage.

#### 6. Performance Data

The VENUS Lumbar Intervertebral body Fusion Cage devices were tested according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.

- Comparison of the technology characteristics of the device to predicate and legally 7. marketed devices
There are no significant differences between the VENUS Lumbar Intervertebral body Fusion Cage System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

#### 8. Conclusion

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

Traditional 510(K)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

#### Public Health Service

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

OCT 2 4 2011

L & K Biomed Co., LTD. % Ms. Hee Kyeong Joo Room 1104, Ace High-End Tower 3, 371-50 Gasan-Dong, Geumcheon-gu, Seoul 153-803, Republic of Korea

Re: K110783

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: October 07, 2011 Received: October 11, 2011

Dear Ms. Joo:

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

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## Page 2 - Ms. Hee Kyeong Joo

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,

Eriul Keith

For 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

510(k) Number : K110783

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 spóndylolistesis 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 _ V _ V (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)

Division of Surgical, Orthopedic, and Restorative Devices

| Traditional 510(K) | Page 16/44 |
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| Pg 1 of 1 | 510(k) Number | K110783 |
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