TRANS1 AXIAL FIXATION SYSTEM

K040426 · Trans1, Inc. · KWQ · Dec 17, 2004 · Orthopedic

Device Facts

• Record ID: K040426
• Device Name: TRANS1 AXIAL FIXATION SYSTEM
• Applicant: Trans1, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TranS1 Axial Fixation System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion. The TranS1 Axial Fixation 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 Axial Fixation 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 spine at L5-S1 in conjunction with legally marketed pedicle screw systems.

Device Story

TranS1 Axial Fixation System provides anterior spinal stabilization at L5-S1; used as adjunct to spinal fusion. System comprises titanium alloy implants (threaded rod/screw, screw plug) and titanium/stainless steel instrumentation (drivers, inserter). Device used by surgeons in clinical setting to provide supplemental fixation in conjunction with pedicle screw systems. Implants provide mechanical support to spinal segment; intended to facilitate fusion process in patients with degenerative conditions. Benefits include stabilization of lumbar spine segment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy implants; titanium alloy and stainless steel instrumentation. Form factor: Multi-component system including 3D axial fixation threaded rod/screw and screw plug. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring fusion for pseudoarthrosis, failed previous fusion, spinal stenosis, Grade 1-2 spondylolisthesis, or discogenic back pain with confirmed disc degeneration. Contraindicated for severe scoliosis, Grade 3-4 spondylolisthesis, tumor, or trauma. Limited to L5-S1 anterior supplemental fixation with pedicle screws.

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

• K-Centrum Anterior Spinal Fixation System (K002371)

Submission Summary (Full Text)

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DEC 17 2004

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## 510 (k) Summary {As required by 21 CFR 807.92 (c)}

- Date of Summary 1. November 30, 2004
### Submitter Information 2.

| Submitter's Name and Address | Submitter's Contact Person |
|------------------------------------------|-------------------------------|
| TranS1 Incorporated | Cheryl Wagoner |
| 1800 Sir Tyler Drive, Suite 101 | Quality Manager |
| Wilmington, NC 28409 | Phone: [phone] |
| Establishment Registration #: 3004578806 | Fax: [phone] |
| | Email: [e-mail] |

#### Device Names 3.

| Proprietary Name: | TranS1 Axial Fixation 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 |

#### 4. Predicate Device

The TranS1 Axial Fixation System is substantially equivalent to:

| Manufacturer | Device | 510 (k) | Cleared |
|-----------------------|----------------------------------------------|---------|------------|
| Spineology Group, LLC | K-Centrum Anterior Spinal Fixation<br>System | K002371 | 09/15/2000 |

#### 5. Device Description

The TranS1 Axial Fixation System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. The following components are included: 3D Axial Fixation Threaded Rod/Screw, Axial Fixation Screw Plug, Axial Fixation Screw Driver, Material Inserter, and Axial Fixation Screw Plug Driver.

#### Intended Use and Indications for Use 6.

The TranS1 Axial Fixation System is intended to provide anterior stabilization of the L5-S1 spinal segment as an adjunct to spinal fusion.

The TranS1 Axial Fixation 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 Axial Fixation 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 spine at L5-S1 in conjunction with legally marketed pedicle screw systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three curved lines resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Ms. Cheryl L. Wagoner TranS1 Incorporated 1800 Sir Tyler Drive Suite 101 Wilmington, North Carolina 28405

Re: K040426

Trade/Device Name: TranS1™ Axial Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 30, 2004 Received: December 1, 2004

Dear Ms. Wagoner:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaller broke is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to conninered proc to ritty 20, 1978, as essordance with the provisions of the Federal Food, Drug, de vices mar nave occh routes and require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merclore, mains of the Act include requirements for annual registration, listing of general controll provision 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 If your device is exassinod (600 as controls. Existing major regulations affecting your device can may be subject to bach addent 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 r tease oc devilode that I Drivision that your device complies with other requirements of the Act that I Drivas Intactions 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 - Ms. Cheryl L. Wagoner

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/dsma/dsmamain.html

Sincerely yours,

Colin M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K040426

Device Name: TranS1™ Axial Fixation System

Indications for Use:

The TranS1™ Axial Fixation 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™ Axial Fixation 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 spine at L5-S1 in conjunction with legally marketed pedicle screw systems.

Prescription Use _ V _ (Part 21 CFR801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Wilkerson

(Division Sign-Off)

**Division of General, Restorative,**
**and Neurological Devices**

510(k) 1

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