FOCUS SPINAL SYSTEM

K120140 · L&K BIOMED Co., Ltd. · NKB · Feb 15, 2012 · Orthopedic

Device Facts

• Record ID: K120140
• Device Name: FOCUS SPINAL SYSTEM
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Feb 15, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients. When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Device Story

FOCUS Spinal System; pedicle screw spinal system for thoracic, lumbar, and sacral spine stabilization. Components include cannulated polyscrews, straight/curved rods, crosslinks, and set screws. Used by surgeons in open or percutaneous MIS surgical approaches to provide immobilization as an adjunct to fusion. Implants accommodate patient anatomy via various diameters and lengths. Benefits include stabilization of spinal segments in patients with degenerative disc disease, trauma, or deformities. Device is non-sterile.

Clinical Evidence

Bench testing only. Static compression bending, tension, torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case screw construct. Results demonstrated performance equivalent to the predicate device.

Technological Characteristics

Materials: Titanium alloy (ASTM F136). Components: Cannulated polyscrews, straight/curved rods, crosslinks, set screws. Approach: Open or percutaneous MIS. Sterilization: Provided non-sterile.

Indications for Use

Indicated for skeletally mature patients requiring noncervical pedicle fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or failed previous fusion. Used as an adjunct to fusion via open or percutaneous MIS approach.

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

• VENUS BASIC Spinal Fixation System (K100706, K103085)
• FOCUS Spinal System (K112643)

Submission Summary (Full Text)

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L & K BIOMED

## 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>Phone.[phone]<br>FAX.[phone] |
|----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Hee Kyeong Joo<br>[e-mail] |
| | Date prepared: | January 13, 2012 |

### 2. Device Identification

| Proprietary Name | FOCUS Spinal System |
|---------------------|----------------------------------------|
| Common Name | Pedicle Screw Spinal System |
| Product Code | MNI, MNH, NKB |
| Classification Name | Pedicle Screw Spinal System (888.3070) |
| Regulatory Class | Class III |

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

• L&K BIOMED: VENUS BASIC Spinal Fixation System (K100706, K103085) FOCUS Spinal System (K112643)

### 4. Description of the Device

FOCUS Spinal System consists of cannulated polyscrews, straight rods, curved rods, crosslinks and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.

Special 510(K)

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### 5. Indications for Use

The FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

## 6. Comparison of the technology characteristics of the device to predicate and legally marketed devices

There are no significant differences between the FOCUS Spinal 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 and intended use.

### 7. Performance Data

Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, screw construct. The mechanical test results demonstrated that the FOCUS Spinal System performs as well as the predicate device.

#### 8. Conclusion

The FOCUS Spinal System is substantially equivalent to the devices referenced above and is therefore safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

FEB 1 5 2012

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

Re: K120140

Trade/Device Name: FOCUS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: January 17, 2012 Received: January 18, 2012

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

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Page 2 - Ms. Hee Kyeong Joo

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 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,

Eunice D. Keith

JorMark 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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Image /page/4/Picture/1 description: The image shows the number K120140 written in a handwritten style. Below the number is the logo for L&K BIOMED. The logo is in black and white and has a small circle to the right of the text.

# Indications for Use

510(k) Number : K120140

Device Name : FOCUS Spinal System

Indications for Use :

The FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); turnor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Special 510(K) | (Division Sign-Off) | Page 9/ 51 |
|----------------|-----------------------------------------------------------|------------|
| | Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K120140 | |

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