(88 days)
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No
The summary describes a mechanical implant system for spinal stabilization and fusion, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as providing "stabilization to permit the biological process of spinal fusion to occur" in the treatment of various spinal instabilities and conditions such as fracture, tumor, and degenerative disc disease. This indicates an active role in treating a medical condition rather than just diagnosis or monitoring.
No
Explanation: The device, the Synthes TSLP System, is described as a surgical implant (plate and screws) used for stabilization of the spine to facilitate fusion. Its intended use is for treatment of various spinal conditions, not for diagnosis.
No
The device description explicitly states that the system consists of physical components: a range of plate sizes and 5.5 mm cancellous screws, both manufactured from Titanium alloy. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Synthes TSLP System Function: The description clearly states that the Synthes TSLP System is a surgical implant (plates and screws) used to stabilize the spine within the body. It is a mechanical device used for structural support and to facilitate fusion, not for testing biological samples.
The information provided describes a surgical implant, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Synthes TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1 - L5) 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), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Product codes
KWQ
Device Description
The Synthes Thoracolumbar Spine Locking Plate (TSLP) System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterolateral aspect of the vertebral body of the thoracolumbar spine (levels T1-L5) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracolumbar (T1 - L5) spine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
APR 2 2 2002
Synthes Spine 510(k) Premarket Notification Thoracolumbar Spine Locking Plate (TSLP) System
11.0 510(K) SUMMARY
DESCRIPTION
The Synthes Thoracolumbar Spine Locking Plate (TSLP) System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterolateral aspect of the vertebral body of the thoracolumbar spine (levels T1-L5) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.
INDICATIONS
The Synthes TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1 - L5) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
KO20244"P /4
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle.
Public Health Service
APR 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vikki Hoffman Senior Regulatory Affairs Associate Synthes Spine 1380 Enterprise Drive West Chester, Pennsylvania 19380
Re: K020244
Trade Name: Synthes Thoracolumbar Spine Locking Plate (TSLP) System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: January 23, 2002 Received: January 24, 2002
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.
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Page 2 - Ms. Vikki 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/dsma/dsmamain.html
Sincerely yours,
Mark M. Milkerson
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Synthes Spine 510(k) Premarket Notification Thoracolumbar Spine Locking Plate (TSLP) System
3.0 FDA INDICATIONS FOR USE FORM
510(k) Number (if known): KOQ U244
Device Name:
Synthes Thoracolumbar Spine Locking Plate (TSLP) System
INDICATIONS FOR USE:
The Synthes TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1 - L5) 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), scoliosis, kyphosis, lordosis, 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 A. Milliken
(Division Sign-Off) Division Sign-Ont)
Reston of General, Restorative (vision of General Devices rision of other on one of Neurological Neurological Neurological Neurological Neurological Neurological Neurological Neurological Neurological Neurological Neurological Neuro
(k) Number
の