(83 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for spinal stabilization and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for the treatment of pain and instability in the spine, which are therapeutic interventions.
No
Explanation: The device is a system of plates and screws used for stabilization in spine surgery, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components (plates and screws) made of Titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in surgical procedures to treat spinal instability. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device consists of plates and screws designed for implantation into the spine to provide stabilization. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The Synthes Anterior Tension Band System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar / lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar / lumbosacral spine (levels L1-S1)
Indicated Patient Age Range
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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KO22791 PAGE 1/1
NOV 1 3 2002
Synthes Spine 510(k) Premarket Notification Anterior Tension Band (ATB) System
11.0 510(K) SUMMARY
DESCRIPTION
The Synthes Anterior Tension Band System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar / lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.
INDICATIONS
The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 13 2002
Vikki M. Hoffman Senior RA Associate Synthes Spine 1690 Russell Road Paoli, Pennsylvania 19301
Re:
K022791 Synthes Anterior Tension Band (ATB) System Trade Name: 21 CFR 888.3060 Regulation Number: Spinal Intervertebral Fixation Orthosis Regulation Name: Regulatory Class: Class II KWQ Product Code: Dated: August 20, 2002 August 22, 2002 Received:
Dear Ms. Hoffman:
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 -- Ms. Vikki M. Hoffman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsmamain.html.
Sincerely yours,
Sincerely, yours,
L. Mark N. Milikens
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Synthes Spine 510(k) Premarket Notification Anterior Tension Band (ATB) System
3.0 FDA INDICATIONS FOR USE FORM
510(k) Number (if known): K 022791
Device Name: Synthes Anterior Tension Band (ATB) System
INDICATIONS FOR USE:
The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR Over-The-Counter Use
Mark H. Milliken
(Division Sign-Off) Division of General, Restorati and Neurological Devices
510(k) Number KC
CONFIDENTIAL