(196 days)
Not Found
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as providing stabilization of a spinal segment(s) as an adjunct to spinal fusion and is indicated for conditions such as trauma, spinal stenosis, deformities, and degenerative disc disease, all of which aim to treat or alleviate a medical condition.
No
Explanation: The device, the Tension Band Anterior Spinal System, is described as being intended for unilateral screw fixation of the spine and for providing stabilization as an adjunct to spinal fusion. It consists of hardware like rods, hooks, and screws. There is no mention of it being used to collect, analyze, or interpret data for the purpose of diagnosis. Its function is therapeutic/surgical, not diagnostic.
No
The device description explicitly lists hardware components such as rods, hooks, wedges, and screws, indicating it is a physical implant system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant system (rods, hooks, screws, etc.) intended for fixation and stabilization of the spine during surgery. It is a physical device implanted in the body, not a device used to analyze samples outside the body.
The description and intended use are consistent with a surgical implant or spinal fixation system, not an IVD.
N/A
Intended Use / Indications for Use
The Tension Band Anterior Spinal System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T7 to L5. The TBA Spinal System is intended to provide stabilization of a spinal segment(s) as an adjunct to spinal fusion. Indications for the use of this device include trauma, spinal stenosis, deformities or curvatures (e.g., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Product codes
KWQ
Device Description
The Tension Band Anterior (TBA) Spinal System includes rods, hooks, wedges, and bone (vertebral) and lockdown screws. A single rod diameter and a range of hook sizes with size-matched bone screws are available. Wedges and lockdown screws serve as the interconnection mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterolateral thoracolumbar spine from T7 to L5
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kollis)
510(k) Summary
| Sponsor: | Spinal Implant Simplification Systems, LLC
72 Oakview Avenue
Maplewood, NJ 07040 | NOV 07 2007 | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|
| Contact
Person: | Matthew E. Lewis, Chief Operating Officer | | |
| Proposed
Trade Name: | Tension Band Anterior Spinal System | | |
| Classification
Name: | Spinal Intervertebral Body Fixation Orthosis | | |
| Regulation: | CFR §888.3060 | | |
| Regulatory
Class: | Class II | | |
| Device Product
Code: | KWQ | | |
| Device
Description: | The Tension Band Anterior (TBA) Spinal System includes rods, hooks, wedges,
and bone (vertebral) and lockdown screws. A single rod diameter and a range of
hook sizes with size-matched bone screws are available. Wedges and lockdown
screws serve as the interconnection mechanism. | | |
| Intended Use: | The Tension Band Anterior Spinal System is intended for unilateral screw
fixation of the anterolateral thoracolumbar spine from T7 to L5. The TBA Spinal
System is intended to provide stabilization of a spinal segment(s) as an adjunct
to spinal fusion. Indications for the use of this device include trauma, spinal
stenosis, deformities or curvatures (e.g., scoliosis, kyphosis and/or lordosis),
tumor, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined
as back pain of discogenic origin with degeneration of the disc confirmed by
history and radiographic studies. | | |
| Materials: | The Tension Band Anterior Spinal System components are manufactured from
stainless steel (ASTM F138 & F2229). | | |
| Substantial
Equivalence: | Documentation was provided which demonstrated the Tension Band Anterior
Spinal System to be substantially equivalent to previously cleared devices. The
substantial equivalence is based upon equivalence in indications for use,
anatomic sites, performance and material of manufacture. | | |
Image /page/0/Picture/3 description: The image shows a page number and a figure number. The text "Page 101 of 101" is at the top of the image. Below that, the text "Fig 1. of 1" is written in a handwritten style.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spinal Instrumentation Simplification Systems, LLC % Ms. Karen E. Warden, PhD 8202 Sherman Road Chesterland, Ohio 44026
NOV 0 7 2007
Re: K071151
Trade/Device Name: Tension Band Anterior Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 26, 2007 Received: September 27, 2007
Dear Dr. Warden:
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 (OS) 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. Karen E. Warden, PhD
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 (240) 276-0120. 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clara Brielun
sto
Mark N. Melke Director Division of General, Restorative and Neurologic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K07)15 |
Device Name: Tension Band Anterior Spinal System
Indications for Use:
The Tension Band Anterior Spinal System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T, to L5. The TBA Spinal System is intended to provide stabilization of a spinal segment(s) as an adjunct to spinal fusion. Indications for the use of this device include trauma, spinal stenosis, deformities or curvatures (e.g., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buel
Division Sign
Division of General, Restorative. and Neurological Devices
510(k) Number K071151
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