TRANS1 AXIALIF 2-LEVEL OR II SYSTEM

• K Number: K073643
• Device Name: TRANS1 AXIALIF 2-LEVEL OR II SYSTEM
• Manufacturer: TRANS1 INCORPORATED
• Date Cleared: 2008-04-28 ( 124 days)
• Product Code: KWQ
• Regulation Number: 888.3060

Intended Use

TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL 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® 2-LEVEL 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® 2-LEVEL 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® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on a physical implant and surgical system for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is intended to treat medical conditions such as pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis, or degenerative disc disease, as an adjunct to spinal fusion.

Diagnostic

No

The document describes the TranS1® AxiaLIF® 2-LEVEL System as a device intended for surgical intervention (stabilization, discectomy, fusion) and not for identifying or characterizing a disease or condition. Its purpose is treatment, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is made of medical grade titanium alloy, indicating it is a physical implant and not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Device Description and Intended Use: The provided text clearly describes a surgical implant (spinal fusion system) used to stabilize the spine. It is implanted directly into the body and does not involve the analysis of in vitro specimens.

The device is a surgical implant used for spinal fusion, not a diagnostic tool that analyzes samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL 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® 2-LEVEL 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® 2-LEVEL 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.

Product codes

KWQ

Device Description

The Trans1® AxiaLIF® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

L4-S1 spinal segments, lumbar spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

TranS1® AxiaLIF® System

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.

Summary

0

Premarket Notification [510(k)] Summary

Prepared: March 31, 2008

APR 2 8 2008

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular 807.92, the following summary of information is provided:

Submitter Information

TranS1 Incorporated 411 Landmark Drive Wilmington, NC 28412

Application Contacts:

Robert Sheridan	Bill Jackson
Senior Advisor to TranS1 Inc.	Vice President of Regulatory, Clinical, and Quality
Same address and fax as above	Same address and fax as above,
Phone: [phone]	Phone: [phone]
[e-mail]	[e-mail]

Device Names

Proprietary Name:	TranS1® AxiaLIF® II System
Common/Usual Name:	Anterior spinal fixation system
Classification Name:	Spinal Intervertebral Body Fixation Orthosis
(21 CFR 888.3060)
Regulatory Classification	Class II
Product Code:	KWQ
FDA Panel Code:	87 Orthopedics

Device Description

The Trans1® AxiaLIF® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.

Intended Use and Indications for Use

TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL 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.

Tran 1"

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Tran - "

The AxiaLIF® 2-LEVEL 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® 2-LEVEL 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.

Substantial Equivalence

Documentation was provided to demonstrate that the TranS1® AxiaLIF® II System is substantially equivalent to the TranS1® AxiaLIF® System.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TranS1 Incorporated % Mr. Robert Sheridan Senior Advisor to TranS1 Inc. 411 Landmark Drive Wilmington, NC 28412

APR 2 8 2008

K073643 Re: Trade/Device Name: TranS1® AxiaLIF II Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 22, 2008 Received: April 23, 2008

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone]or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Miller

Mark N. Melkerson · Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tranti

Statement of Indications for Use

510(k) Number: K073643

Device Name: TranS1® AxiaLIF II

Indications for Use:

TranSI® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL 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® 2-LEVEL 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® 2-LEVEL 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.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil hp Oylm for mxm
(Division Sign-Off) Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K073643