(116 days)
Not Found
No
The 510(k) summary describes a mechanical fixation system and does not mention any AI/ML components or capabilities.
Yes
The device is described as a "Fixation System" intended "as an adjunct to fusion for treatment of thoracic spinal instability," which directly addresses a health condition.
No
The device is a Thoracic Fixation System, an implantable system used to stabilize the spine, not to diagnose medical conditions. Its intended use is as an adjunct to fusion for treating spinal instability.
No
The device description explicitly states that the device includes plates and screws manufactured from medical grade titanium alloy, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to stabilize the thoracic spine for various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details plates and screws made of titanium alloy, which are physical implants for surgical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The BodyForm™ Thoracic Fixation System is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The BodyForm™ Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis.
The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from T1 to L1.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The purpose of this submission is for additional sizes of plates and screws for the BodyForm™ Fixation System. This submission includes smaller sized plates and screws intended for the thoracic region of the spine. All implant components are manufactured from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic region of the spine, T1 to L1 (vertebral bodies)
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)
Theken Spine, LLC believes sufficient evidence exists to reasonably conclude that the BodyForm™ Thoracic Fixation System is substantially equivalent to other legally marketed predicate devices. This is based on the design concept, the use of established known materials, feature comparisons, mechanical testing, indications for use, and engineering analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Theken Spine, LLC
BodyForm™ Thoracic Fixation System
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510(k) Summary (21 CFR Part 807.92)
Submitter Information A. Submitter's Name: Theken Spine, LLC Address: 283 E. Waterloo Akron, Ohio 44319 DEC 2 1 2007 Telephone Number: 330-773-7677 x221 Fax Number: 330-773-7697 Contact Person: Dale Davison Date Prepared: 8/21/07 Device Information B. BodyForm™ Thoracic Fixation System Trade Name: Anterior Spinal Fixation System Common Name: Classification: KWQ 888.3060 - Spinal Intervertebral Body Fixation Orthosis Predicate Device: BodyForm™ Thoraco-Lumbar Fixation System, Theken Spine, LLC (K983622) Thoracolumbar Spine Locking Plate System, Synthes (K020244) Coral Spinal System, Theken Spine, LLC (K041592) The purpose of this submission is for additional sizes of plates and Device Description: screws for the BodyForm™ Fixation System. This submission includes smaller sized plates and screws intended for the thoracic region of the spine. All implant components are manufactured from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136. The BodyForm™ Thoracic Fixation System is intended as an Intended Use: adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis. The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebrah bodies at levels of fixation from T1 to L1. Implant grade titanium alloy Ti 6A1-4V (ELI) per ASTM F-136 Material Composition: and ISO 5832-3.
C. Substantial Equivalence
Theken Spine, LLC believes sufficient evidence exists to reasonably conclude that the BodyForm™ Thoracic Fixation System is substantially equivalent to other legally marketed predicate devices. This is based on the design concept, the use of established known materials, feature comparisons, mechanical testing, indications for use, and engineering analysis.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2007
Theken Spine, LLC % Mr. Dale Davison 283 E. Waterloo Akron. OH 44319
Re: K072407
Trade/Device Name: BodyForm™ Thoracic Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 17, 2007 Received: December 17, 2007
Dear Mr. Davison:
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.
2
Page 2 – Mr. Dale Davison
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 Revorting (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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K072407
BodyForm™ Thoracic Fixation System Theken Spine, LLC
Indications for Use
510(k) Number (if known):
The BodyForm™ Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis.
The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from T1 to L1.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Barbara Breech
Division of General, Restorative, and Neurologic ... Devices
510(k) Number K072407
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