(20 days)
Not Found
No
The device description and summary of performance studies focus on mechanical components and testing, with no mention of AI or ML.
Yes
The device is intended for the treatment of various spinal instabilities, including fractures, tumors, degenerative disc disease, and spinal deformities, which is a therapeutic purpose.
No
The device description indicates that the GATEWAY™ Thoracolumbar Plate System is an implantable system used for fixation in the thoracolumbar spine (T1-L5) to treat instability. This is a therapeutic device designed for surgical intervention rather than diagnosing a condition.
No
The device description clearly outlines physical components made of titanium alloy (plates, screws, locking caps, staples) intended for surgical implantation. This is a hardware-based medical device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The GATEWAY™ Thoracolumbar Plate System is a surgical implant designed to stabilize the spine. It consists of plates, screws, and other hardware that are physically implanted into the patient's body.
- Intended Use: The intended use is to treat spine instability by providing structural support. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant for structural support of the spine, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GATEWAY™ Thoracolumbar Plate System is intended for use in the treatment of 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 failed previous spine surgery.
Product codes
KWQ
Device Description
The GATEWAY™ Thoracolumbar Plate System consists of plates of various lengths to be used with polyaxial or monoaxial REVERE™ screws and variable or fixed bone screws. Polyaxial or monoaxial REVERE™ screws attach to the rod portion of the plate and variable or fixed bone screws are inserted through the plate, for fixation of GATEWAY plates to the vertebral bodies of the thoracolumbar spine (T1-L5). REVERE™ locking caps are used to connect polyaxial or monoaxial screws to the rod portion of the plate. Optional staples may be used for additional fixation of polyaxial or monoaxial screws to vertebral bodies. Implants are composed of titanium alloy, as specified in ASTM F136. F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1-L5) spine
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
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 3, 2004 is presented.
Key Metrics
Not Found
Predicate Device(s)
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
K062407
510(k) - GATEWAY™ System
510(k) Summary
SUBMITTED BY:
Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker
SEP - 6 2006
DEVICE NAME:
GATEWAY™ Thoracolumbar Plate System
CLASSIFICATION:
21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Codes KWQ. Regulatory Class II. Panel code 87.
PREDICATE DEVICES:
Globus REVERE™ Stabilization System K061202 (SE date July 20, 2006) DePuy Profile Anterior Thoracolumbar Plate K973060 (SE date Nov 3. 1997), Product codes KWQ. Regulatory Class II.
DEVICE DESCRIPTION:
The GATEWAY™ Thoracolumbar Plate System consists of plates of various lengths to be used with polyaxial or monoaxial REVERE™ screws and variable or fixed bone screws. Polyaxial or monoaxial REVERE™ screws attach to the rod portion of the plate and variable or fixed bone screws are inserted through the plate, for fixation of GATEWAY plates to the vertebral bodies of the thoracolumbar spine (T1-L5). REVERE™ locking caps are used to connect polyaxial or monoaxial screws to the rod portion of the plate. Optional staples may be used for additional fixation of polyaxial or monoaxial screws to vertebral bodies. Implants are composed of titanium alloy, as specified in ASTM F136. F1295.
INTENDED USE:
The GATEWAY™ Thoracolumbar Plate System is intended for use in the treatment of 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 failed previous spine surgery.
PERFORMANCE DATA:
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 3, 2004 is presented.
1
BASIS OF SUBSTANTIAL EQUIVALENCE:
The GATEWAY™ Thoracolumbar Plate System implants are similar to the predicate Globus REVERE™ Stabilization System (K061202) and DePuy Profile Anterior Thoracolumbar Plate System (K973060), with respect to technical characteristics, performance, and intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Globus Medical % Kelly Baker, PhD Director, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K062407
Trade/Device Name: GATEWAY™ Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 16, 2006 Received: August 17, 2006
Dear Dr. Baker:
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 adultcration.
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.
3
Page 2 - Kelly Baker, 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 Office of Compliance at (240) 276- 0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Sincerely, yours,
Barbara Buckland
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) - GATEWAY™ System
Indications for Use Statement ll.
4062407 510(k) Number:
GATEWAY™ Thoracolumbar Plate System Device Name:
Indications:
The GATEWAY™ Thoracolumbar Plate System is intended for use in the treatment of 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 failed previous spine surgery.
Prescription Use __ X (Per 21 CFR §801.109) Over-The-Counter Use
(PLEASE DO NOT WRITE ON THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buettner
Division of General, Restorative, and Neurological Devices
510(k) Number K062407