LEXUS ANTERIOR CERVICAL PLATE SYSTEM

K113509 · L&K BIOMED Co., Ltd. · KWQ · Jan 20, 2012 · Orthopedic

Device Facts

• Record ID: K113509
• Device Name: LEXUS ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis.

Device Story

LEXUS Anterior Cervical Plate System; titanium alloy (Ti-6Al-4V ELI) plates and screws for anterior cervical spine (C2-C7) fixation. System includes plates for 1-4 level procedures and 3.5mm/4.0mm diameter bone screws (fixed/variable, self-tapping/self-drilling). Used by surgeons in clinical settings to immobilize/stabilize spine as adjunct to fusion. Mechanical fixation provides structural support to facilitate bone healing; benefits patient by restoring spinal stability.

Clinical Evidence

No clinical data. Bench testing only. Static compression, tension, torsion, and dynamic compression bending performed per ASTM F1717 on worst-case construct; results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F136). Components: Plates (1-4 level) and 3.5mm/4.0mm diameter bone screws (fixed/variable, self-tapping/self-drilling). Mechanical testing: ASTM F1717. Non-powered, mechanical fixation device.

Indications for Use

Indicated for patients requiring spinal immobilization/stabilization as an adjunct to fusion in the cervical spine (C2-C7) due to degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusion, or spinal stenosis.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Maxima™ Anterior Cervical Plate System (K061002)
• Synthes Anterior Cervical Locking Plate(ACLP) System (K031276)
• ZEPHIR™ Anterior Cervical Plate System (K994239, K030327)

Submission Summary (Full Text)

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

KII 3509

JAN 2 0 2012 L&K BIOME

### 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. |
|----|-----------------|-----------------------------------------------------|
| | | #1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong |
| | | Geumcheon-gu, Seoul 153-803 Republic of Korea |
| | | Phone. [phone] |
| | | FAX. [phone] |
| | Contact Person: | Hee Kyeong Joo |
| | Prepared Date | November 24, 2011 |

#### 2. Device Identification

| Trade Name | LEXUS Anterior Cervical Plate System |
|-----------------------|----------------------------------------------|
| Common Name | Anterior Cervical Plate |
| Classification Name | Spinal Intervertebral Body Fixation Orthosis |
| Regulation Number | 21 CFR 888.3060 |
| Product Code | KWQ |
| Device Classification | Class II |

#### 3. Identification of Legally Marketed Devices

- U&I Corporation: Maxima™ Anterior Cervical Plate System (K061002) .
- . Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K031276)
- Medtronic: ZEPHIR™ Anterior Cervical Plate System(K994239, K030327) .

#### 4. Description of the Device

The LEXUS Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6A1-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the LEXUS Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable selftapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.

Pg 1 of 2

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

# KI13509

Image /page/1/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a bold, sans-serif font. Above the text is a graphic element that appears to be a stylized circle or ring made up of smaller circles or dots. The overall design is simple and modern.

#### 5. Intended use

The LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, •
- trauma (i.e. fractures or dislocations), .
- tumors. .
- . deformity (defined as kyphosis, lordosis or scoliosis),
- pseudarthrosis, .
- failed previous fusion, t
- spinal stenosis.

#### 6. Comparison of the Technology Characteristics

The LEXUS Anterior Cervical Plate System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials, substantially equivalent performance characteristics and the same intended use.

#### 7. Discussion of the Non-Clinical Testing

Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the LEXUS Anterior Cervical Plate System performs as well as the predicate device.

#### 8. Conclusion

The LEXUS Anterior Cervical Plate 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a triple-stranded helix representing the interconnectedness of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.

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

JAN 2 0 2012

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: K113509

Trade/Device Name: LEXUS Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 24, 2011 Received: November 28, 2011

Dear Ms. Hee Kyeong 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

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

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 yours

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}------------------------------------------------

K113509

Image /page/4/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in bold, black letters. Above the text is a smaller line of text that is difficult to read. To the right of the text is a circular graphic that is also in black.

## Indications for Use Statement

510(k) Number (if known): K113509

Device Name: LEXUS Anterior Cervical Plate System

#### Indications For Use:

The LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, י
- trauma (i.e. fractures or dislocations), ,
- tumors. .
- deformity (defined as kyphosis, lordosis or scoliosis), .
- pseudarthrosis, .
- failed previous fusion, .
- spinal stenosis.

| Prescription Use | <div style="display:flex; flex-direction:column; align-items:center;">√<hr style="width:50px;text-align:left;margin-left:0"/></div> |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| (Part 21 CER801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | <hr style="width:50px;text-align:left;margin-left:0"/> |
| (21 CER801 Subpart C) | |

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

| Concurrence of CDRH, Office of Device Evaluation (OED) |
|-------------------------------------------------------------------|
| (Division Sign-Off) |
| Division of Surgical, Orthopedic, and Restorative Devices |

| 510(k) Number | K113509 |
|---------------|---------|
|---------------|---------|

LEXUS Anterior Cervical Plate System

Pg 1 of 1