VENUS SPINAL FIXATION SYSTEM

K120270 · L&K BIOMED Co., Ltd. · NKB · Mar 26, 2012 · Orthopedic

Device Facts

• Record ID: K120270
• Device Name: VENUS SPINAL FIXATION SYSTEM
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Mar 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: - degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); - spondylolisthesis; - trauma (i.e., fracture or dislocation); - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); - tumor; - stenosis, and - failed previous fusion (pseudoarthrosis) The VENUS 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 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 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, spinal tumor and failed previous fusion (pseudoarthrosis).

Device Story

System comprises titanium alloy and CoCrMo alloy screws, set screws, rods, crosslinks, and connectors; used for spinal immobilization and stabilization. Implanted by surgeons in clinical settings to provide structural support as adjunct to fusion. Components stabilize thoracic, lumbar, and sacral segments; facilitate bone healing in patients with degenerative, traumatic, or deformity-related spinal instability. Benefits include restoration of spinal alignment and stabilization of segments to promote fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F1717-10 (static compression bending, static tension, static torsion, dynamic compression bending) and ASTM F1798 (gripping-push down). No clinical data provided.

Technological Characteristics

Materials: Titanium-6Al-4V ELI (ASTM F136) and CoCrMo alloy (ASTM F1537). Components: screws (4.0-8.5mm diameter, 20-150mm length), rods, set screws, crosslinks, connectors. Mechanical fixation system; non-active; no software or electronics.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical spinal fixation (T1-S2/ilium posterior or T8-L5 anterolateral) as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis (including severe Grade 3-4 L5-S1), trauma (fracture/dislocation), deformities (scoliosis, kyphosis, lordosis), tumor, stenosis, and failed previous fusion.

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

• L&K BIOMED: VENUS Spinal Fixation System (K100706, K103085)
• GS Medical: Anyplus Spinal Fixation System (K091717)
• Spine Craft: APEX Spine System (K062513, K092825, K102488)
• Stryker Spine: Xia®III Spinal System (K071373, K083393, K091291)
• Synthes Spine: USS Polyaixal and Synthes USS Iliosacral System (K022949, K082572)

Submission Summary (Full Text)

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ge 1 of 2.

MAR 2 6 2012

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 |
|----|-----------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Hee Kyeong Joo<br>Telephone. [phone]<br>FAX .[phone]<br>[e-mail] |
| | Prepared Date | January 25, 2012 |

#### Device Identification 2.

| Trade Name: | VENUS Spinal Fixation System |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Product Code: | NKB, KWP, KWQ, MNH, MNI |
| Class | Class III |
| Classification<br>Name: | 1) Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050<br>2) Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060<br>3) Pedicle Screw Spinal System, 21 CFR §888.3070 |

# 3. Identification of Legally Marketed Devices

L&K BIOMED: VENUS Spinal Fixation System (K 100706,K 103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825,K102488) Stryker Spine: Xia®III Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes USS Iliosacral System (K022949,K082572)

# 4. Device Description

This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4 Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

# 5. Intended use / Indications for Use

VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

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- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
- spondylolisthesis;
- trauma (i.e., fracture or dislocation);
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- tumor;

●

- stenosis, and
- failed previous fusion (pseudoarthrosis)

The VENUS 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 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 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, spinal tumor and failed previous fusion (pseudoarthrosis).

#### 6. Comparison of the Technology Characteristics

The VENUS Spinal Fixation 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. Performance Data

Non-Clinical Performance and Conclusions:

Bench testing results demonstrate that VENUS Spinal Fixation system performs equivalently to the predicates in static compression bending, static tersion, static torsion, dynamic compression bending (in accordance with ASTM F1717-10) and gripping-push down (in accordance with ASTM F1798).

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

### 8. Conclusion

The VENUS Spinal Fixation System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

MAR 2 6 2012

Re: K120270

Trade/Device Name: VENUS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: January 25, 2012 Received: January 30, 2012

Dear 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 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.

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## Page 2 - Hee Kyeong Joo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice to: Jour Critices/CDRH/CDRHOffices/ucm115809.htm for go to mep.//www.tadiological Health's (CDRH's) Office of Compliance. Also, please the comer for Devices that reading by reference to premarket notification" (21CFR Part note the regulation 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 Tou may 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,

for Peter R

Der

Mark N. Meller

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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L&K BIOMED

# Indications for Use Statement

510(k) Number (if known):

K120270

Device Name: VENUS Spinal Fixation System

#### Indications For Use:

VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L.5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
- spondylolisthesis; ●
- trauma (i.e., fracture or dislocation); .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- . tumor;
- . stenosis, and
- failed previous fusion (pseudoarthrosis) .

The VENUS 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 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 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, spinal tumor and failed previous fusion (pseudoarthrosis).

| Prescription Use | ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ |
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| | |

Over-The-Counter Use

(Part 21 CER801 Subpart D)

(21 CER801 Subpart C)

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

AND/OR

| Concurrence of CDRH, Office of Device Evaluation (OED) | |
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| (Division Sign-Off) | |
| VENUS Spinal Fixation System 510(K) | Page 10/ 126 |
| Division of Surgical, Orthopedic, and Restorative Devices | |

K120270 S10(k) Number