TRANS1 AXIALIF SYSTEM

K050965 · Trans1 Incorporated · KWQ · Jun 14, 2005 · Orthopedic

Device Facts

• Record ID: K050965
• Device Name: TRANS1 AXIALIF SYSTEM
• Applicant: Trans1 Incorporated
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TranS1® AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1@ AxiaLIFTM is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet and pedicle screw systems.

Device Story

TranS1 AxiaLIF System is a multi-component spinal fixation device. It provides axial access to the L5-S1 disc space via a pre-sacral track. Instrumentation is used to distract vertebral bodies and insert bone graft material. An anterior fixation rod is implanted through the track to provide axial stabilization. The system is used by surgeons in a clinical/OR setting. It is intended for use in conjunction with legally marketed facet and pedicle screw systems to provide supplemental anterior fixation. The device benefits patients by facilitating spinal fusion in the lumbar spine.

Clinical Evidence

No clinical trials were conducted for this specific 510(k). Substantial equivalence is supported by biomechanical testing and a review of clinical literature regarding the efficacy of facet screw fixation compared to pedicle screw fixation for posterior stabilization.

Technological Characteristics

System components consist of titanium alloy implants and titanium alloy/stainless steel instrumentation. The device facilitates axial access and stabilization at the L5-S1 disc space. It is a mechanical fixation system; no software, electronics, or energy sources are involved.

Indications for Use

Indicated for patients requiring spinal fusion at L5-S1 for pseudoarthrosis, failed previous fusion, spinal stenosis, Grade 1-2 spondylolisthesis, or discogenic back pain. Contraindicated for severe scoliosis, Grade 3-4 spondylolisthesis, tumor, or trauma.

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

• TranS1 AxiaLIF System (K040426)

Submission Summary (Full Text)

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KosoN65

## Appendix II

### 510 (k) Summary Prepared 4/15/2005

### JUN 1 4 2005

#### Submitter Information

| Submitter's Name and Address | Submitter's Contact Person |
|---------------------------------|--------------------------------|
| TranSI Incorporated | Robert L. Sheridan |
| 1800 Sir Tyler Drive, Suite 101 | VP Regulatory and Clinical |
| Wilmington, NC 28405 | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |

#### Device Names

| Proprietary Name: | TranS1® AxiaLIF™ System |
|----------------------------|------------------------------------------------------------------|
| Common/Usual Name: | Anterior spinal fixation device |
| Classification Name: | 21 CFR 888.3060, Spinal Intervertebral Body Fixation<br>Orthosis |
| Regulatory Classification: | Class II, product code KWQ |

### Predicate Device

The TranS1® AxiaLIF™ System, with a modified indication statement and the subject of this 510(k), is substantially equivalent to the TranS1 AxiaLIF™ System with its original indication statement, cleared under K()40426 on December 17, 2004.

### Device Description

The TranS1® AxiaLIFTM System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral. axial track to the 1.5 - S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.

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## 050965

#### Intended Use and Indications for Use

TranS1® AxiaLIFTM System is intended to facilitate spinal fusion by providing axial access to the L5 -- S1 disc space and axial stabilization of those vertebral bodies. The specific indication originally cleared under K040426 for the System and 3D Axial Rod™ was:

The TranS1® AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIFTM System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spinc at L5 - S1 in conjunction with legally marketed pedicle screw systems.

This 510(k) changes the last sentence of the indication statement to read as follows (the change appears in bold and in brackets):

> Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed [facet and] pedicle screw systems.

### Technological Characteristics Comparisons

The technological characteristics of the TranS1® AxiaLIFTM System have not changed.

#### Summary of Testing

A significant amount of biomechanical and clinical testing of facet screws, and of facet screws in comparison to pedicle screws, appearing in the literature and as performed by TranS1®, establish that facet screw fixation will provided adequate posterior stabilization when used with the anterior stabilization of the AxiaLIF™ 3D Axial Rod™ (which is part of the AxiaLIFTM System).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert L. Sheridan Vice President for Regulatory and Clinical Affairs Trans1 Incorporated 1800 Sir Tyler Drive, Suite 101 Wilmington, North Carolina 28405

Re: K050965

Trade/Device Name: TranS1® AxiaLIF™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 15, 2005 Received: April 19, 2005

Dear Mr. Sheridan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 – Mr. Robert L. Sheridan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Hypt Curles

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix IV

# Indications for Use

510(k) Number (if known):

Device Name: TranS1® AxiaLIFTM System

Indications for Use:

The TranS1® AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1@ AxiaLIFTM is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet and pedicle screw systems.

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)

Hupt. Rlurchs

(Division Sign-Off Division of General, Restorative. and Neurological Devices

**510(k) Number** K080965

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