VENUS BASIC SPINAL FIXATION SYSTEM

K100706 · L&K BIOMED Co., Ltd. · MNH · Jul 22, 2010 · Orthopedic

Device Facts

• Record ID: K100706
• Device Name: VENUS BASIC SPINAL FIXATION SYSTEM
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: MNH · Orthopedic
• Decision Date: Jul 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VENUS BASIC Spinal Fixation System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the VENUS BASIC Spinal Fixation System are 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Device Story

Top-loading posterior spinal fixation system; components include pedicle screws, rods, nuts, and transverse linking mechanism. Used by surgeons in clinical settings to build spinal implant constructs for stabilization and fusion. Implants are non-sterile, single-use, and fabricated from titanium alloy. Specialized instruments provided for application and removal. Output is a rigid construct providing immobilization of spinal segments; aids in promoting spinal fusion. Benefits patient by stabilizing unstable or deformed spinal segments.

Clinical Evidence

Bench testing only. Mechanical testing conducted in accordance with ASTM F1717-04, including static (tension, compression, torsion) and dynamic (fatigue) testing to demonstrate equivalence to predicate devices.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. Components: Pedicle screws, rods, nuts, transverse linking mechanism. Mechanical testing per ASTM F1717. Non-sterile, single-use.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe Spondylolisthesis (Grade 3-4, L5-S1) or acute/chronic instabilities/deformities (degenerative Spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion) of the thoracic, lumbar, and sacral spine.

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

• OPTIMA Spinal System (K031585)
• Global Spinal Fixation System (K001668)
• 4CIS Vane Spine System (K060702)
• EOS Spinal System (K082509)

Submission Summary (Full Text)

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K100706

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JUL 22 2010

## 510(k) SUMMARY

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

# Submission Information

| US Agent: | Kevin Ahn |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Address: | 20505 Valley Blvd, Suite 111 Walnut, CA 91786 |
| Phone No: | 909-595-7746 |
| FAX: | 909-595-7747 |
| E-Mail: | [e-mail] |
| Applicant: | L&K BIOMED Co., Ltd. |
| Address: | Room 1104, ACE High-End Tower 3,<br>371-50, Gasan-dong, Geumcheon-gu, Seoul, 153-803<br>Republic of Korea |
| Phone No: | 82-2-2624-1471 |
| FAX: | 82-2-2624-1477 |
| Manufacturing Site: | Implanova Co.,Ltd. |
| Address : | #104, Gyeongnam Techno-park, 155-1, Nongso-ri, Juchon-<br>myeon, Gimhae, Gyeongnam, 621-842 Republic of Korea |
| Phone No.: | 82-55-329-5292 |
| FAX: | 82-55-329-5294 |
| Official Correspondent: | Hee Kyeong Joo |
| Phone No.: | 82-2-2624-2471 |
| Address: | Room 1104, ACE High-End Tower 3,<br>371-50, Gasan-dong, Geumcheon-gu, Seoul, 153-803<br>Republic of Korea |
| Phone No: | 82-2-2624-1471 |
| FAX: | 82-2-2624-1477 |
| E-mail: | [e-mail] |

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K100706

July 1, 2010 Date prepared:

#### Device Identification

| Trade Name: | VENUS BASIC Spinal Fixation System |
|----------------------|----------------------------------------------|
| Common Name: | Pedicle Screw Spinal Fixation System |
| Classification Name: | Pedicle Screw Spinal System (21CFR 888.3070) |
| Product Code: | MNH, MNI |

#### Substantially Equivalent Predicate Legally Marketed Devices

The subject device, VENUS BASIC Spinal Fixation System, is substantially equivalent to OPTIMA™, Spinal System manufactured by U & I Co., Ltd which was cleared for marketing as K031585, the Global Spinal Fixation System manufactured by D.K.M. Co., Ltd which was cleared for marketing as K001668, the 4CIS Vane Spine System manufactured by Solco Biomedical Co., Ltd which was cleared for marketing as K060702 and the EOS Spinal System manufactured by Korea Bone Bank Co., Ltd which was cleared for marketing as K082509.

#### Device Description

The VENUS BASIC Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The VENUS BASIC Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. VENUS BASIC Spinal Fixation System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the VENUS BASIC Spinal Fixation System

#### Indications for Use

The VENUS BASIC Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in

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skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the VENUS BASIC Spinal Fixation System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

## Performance Data

Mechanical testing as listed in APPENDIX 3 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices.

Mechanical test reports were completed for the following test methods:

- Static test: Tension, Compression and Torsion test report (ASTM F1717-04) -
- Dynamic test: Fatigue test report (ASTM F1717-04) -

#### Conclusion

Testing and other comparisons have established that the VENUS BASIC Spinal Fixation System is substantially equivalent in design, materials, indications, and performance to other predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The text is in all caps and is evenly spaced around the circle.

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

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

JUL 2-2 2010

Re: K100706

Trade/Device Name: VENUS BASIC Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH. MNI Dated: July 13, 2010 Received: July 16, 2010

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/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,

Barbara Buim

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 .

K100706 510(k) Number (if known) :

Device Name : VENUS BASIC Spinal Fixation System

Indications for Use :

The VENUS BASIC Spinal Fixation System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the VENUS BASIC Spinal Fixation System are 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100706

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