AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II

K092124 · Trans1 Incorporated · KWQ · Jan 21, 2010 · Orthopedic

Device Facts

• Record ID: K092124
• Device Name: AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
• Applicant: Trans1 Incorporated
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion. The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

Device Story

System provides anterior stabilization of L4-S1 spinal segments as adjunct to fusion; facilitates minimally invasive access to lower spine for discectomy and interbody fusion. Components include titanium alloy implants and titanium/stainless steel instrumentation. Surgeon uses instruments to create pre-sacral axial tract to L4-S1 disc spaces; distracts vertebral bodies; inserts bone graft material; implants anterior fixation rods. Used in conjunction with legally marketed facet or pedicle screw systems. Provides supplemental fixation to stabilize spine, assisting in fusion process for degenerative conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Multi-component system comprising titanium alloy implants and titanium alloy/stainless steel instrumentation. Designed for minimally invasive pre-sacral axial access to L4-S1 disc spaces. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease (discogenic back pain confirmed by history/radiography). Contraindicated for severe scoliosis, severe spondylolisthesis (Grades 2-4), tumor, trauma, vertebral compression fractures, or compromised vertebral body integrity.

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® II (K073643)

Submission Summary (Full Text)

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K092124

TranS1 AxiaLIF 2L System

Image /page/0/Picture/2 description: The image shows the logo for "Trans1". The logo is in black and white and features a stylized font. The "1" in "Trans1" has a curved line extending from the bottom, and a circled R symbol is located to the right of the "1".

JAN 2 1 2010

# Premarket Notification [510(K)] Summary

(per 21 CFR 807.92)

7/14/2009

| Submitter: | Contact Person: |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| TranS1, Inc.<br>411 Landmark Drive<br>Wilmington, NC 28412 | Cheryl L Wagoner<br>Quality and Regulatory Manager<br>910-332-1703 (phone)<br>910-233-7105 (fax) |
| Proprietary Name: | TranS1® AxiaLIF® 2L System |
| Classification: | Spinal Intervertebral Body Fixation Orthosis<br>21 CFR 888.3060<br>Product Code: KWQ |
| Predicate Device: | TranS1® AxiaLIF® II, K073643 |

#### Intended use:

TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.

The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

## Device Description

The TranS1® AxiaLIF® 2L 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 tract to the LC-1.5-S 1 disc spaces. The track and the device's instruments are used for distracting the L4 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes implantable anterior fixation rods that are implanted through the same tract.

## Technological Characteristics and Substantial Equivalence

The technological characteristics of the TranS1® AxiaLIF® 2L System have not changed.

ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ

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Image /page/1/Picture/1 description: The image contains a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, rendered in black. The emblem is composed of curved lines and shapes, giving it a modern and abstract appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JAN 2 1 2010

TranS1. Inc. % Ms. Cheryl L. Wagoner Quality and Regulatory Manager 411 Landmark Drive Wilmington, North Carolina 28412

Re: K092124

Trade/Device Name: TranS1® AxiaLIF® 2L System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: November 20, 2009 Received: November 23, 2009

Dear Ms. Wagoner:

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 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

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Page 2 - Ms. Cheryl L. Wagoner

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Harbare bouchem

Mark N. Me kerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

Page 1 of 1

K092114 510(k) Number: _

Device Name: TranS1® AxiaLIF® 2L System

Indications for Use:

TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The Axial.IF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny, or for assistance in the performance of L4-S1 interbody fusion.

The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

Over-The-Counter Use Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

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(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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