(57 days)
No
The summary describes a surgical system for spinal fusion, focusing on mechanical components and surgical technique. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is indicated for treating various spinal conditions, including pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis, and degenerative disc disease, which are therapeutic functions.
No
The device description and intended use clearly state that it is a surgical system for spinal fusion and fixation, designed to treat specific conditions. There is no mention of it being used to diagnose diseases or conditions.
No
The device description explicitly states it is a "multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel," indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The TranS1® AxiaLIFTM System is described as a multi-component system including implantable devices (titanium alloy rod) and surgical instruments. It is used for creating a track, distracting vertebral bodies, inserting bone graft, and providing anterior fixation in the lumbar spine.
- Intended Use: The intended use is for surgical fusion to treat various spinal conditions.
The device is a surgical implant and associated instrumentation used directly on the patient's body during a surgical procedure, not for testing samples taken from the body.
N/A
Intended Use / 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.
Product codes
KWQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at L5 - S1
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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: 910-509-3100 |
| Fax: 910-509-3101 | |
| Email: rsheridan@translinc.com |
Device Names
| Proprietary Name: | TranS1® AxiaLIF™ System |
|---|---|
| Common/Usual Name: | Anterior spinal fixation device |
| Classification Name: | 21 CFR 888.3060, Spinal Intervertebral Body Fixation |
| 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.
್ಕರ್
1
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.
3
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 (240) 276-0120 . 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 (800) 638-2041 or (301) 443-6597 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
4
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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