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.
Device Story
Tension Band Anterior (TBA) Spinal System provides spinal stabilization as an adjunct to fusion; used for unilateral screw fixation of anterolateral thoracolumbar spine (T7-L5). System components include rods, hooks, wedges, and bone/lockdown screws. Surgeon implants device during spinal surgery to stabilize segments affected by trauma, stenosis, deformity, tumor, or degenerative disc disease. Interconnection mechanism utilizes wedges and lockdown screws to secure rod-hook-screw construct. Device provides mechanical support to spinal column to facilitate fusion.
Clinical Evidence
No clinical data provided; substantial equivalence based on bench testing and design characteristics.
Technological Characteristics
Components manufactured from stainless steel (ASTM F138 & F2229). System consists of rods, hooks, wedges, and bone/lockdown screws. Mechanical fixation device; no energy source or software.
Indications for Use
Indicated for patients requiring unilateral screw fixation of the anterolateral thoracolumbar spine (T7-L5) for stabilization as an adjunct to spinal fusion. Conditions include trauma, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, failed fusion, or degenerative disc disease.
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.
Submission Summary (Full Text)
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# Kollis)
## 510(k) Summary
| Sponsor: | Spinal Implant Simplification Systems, LLC<br>72 Oakview Avenue<br>Maplewood, NJ 07040 | NOV 07 2007 | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|
| Contact<br>Person: | Matthew E. Lewis, Chief Operating Officer | | |
| Proposed<br>Trade Name: | Tension Band Anterior Spinal System | | |
| Classification<br>Name: | Spinal Intervertebral Body Fixation Orthosis | | |
| Regulation: | CFR §888.3060 | | |
| Regulatory<br>Class: | Class II | | |
| Device Product<br>Code: | KWQ | | |
| Device<br>Description: | The Tension Band Anterior (TBA) Spinal System includes rods, hooks, wedges,<br>and bone (vertebral) and lockdown screws. A single rod diameter and a range of<br>hook sizes with size-matched bone screws are available. Wedges and lockdown<br>screws serve as the interconnection mechanism. | | |
| Intended Use: | The Tension Band Anterior Spinal System is intended for unilateral screw<br>fixation of the anterolateral thoracolumbar spine from T7 to L5. The TBA Spinal<br>System is intended to provide stabilization of a spinal segment(s) as an adjunct<br>to spinal fusion. Indications for the use of this device include trauma, spinal<br>stenosis, deformities or curvatures (e.g., scoliosis, kyphosis and/or lordosis),<br>tumor, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined<br>as back pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies. | | |
| Materials: | The Tension Band Anterior Spinal System components are manufactured from<br>stainless steel (ASTM F138 & F2229). | | |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the Tension Band Anterior<br>Spinal System to be substantially equivalent to previously cleared devices. The<br>substantial equivalence is based upon equivalence in indications for use,<br>anatomic sites, performance and material of manufacture. | | |
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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
pg 1 of 1
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Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
