(27 days)
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No
The device description focuses on the physical components and materials of a cervical plate system, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with various conditions, which aligns with the definition of a therapeutic device.
No
Explanation: This device is a surgical implant (anterior cervical plate system) used for spinal stabilization and fixation, not for diagnosing conditions. Its purpose is to physically support the spine during fusion, not to identify or assess the presence of a disease.
No
The device description explicitly states that the system consists of bone plates and screws manufactured from titanium alloy, which are physical hardware components.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The C-TEK C-Thru Anterior Cervical Plate System is a surgical implant made of titanium alloy. It is designed to be surgically implanted into the cervical spine for stabilization.
- Intended Use: The intended use is for "anterior interbody screw fixation of the cervical spine" and "temporary stabilization of the anterior spine." This is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates a physical implant used in surgery, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The C-TEK C-Thru Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole or slotted hole design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
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
C2 to C7 (cervical 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): 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.
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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.
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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).
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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.
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KO42798 Page 1 of
510(k) SUMMARY
NOV - 4 2004
SUBMITTED BY
Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618
(949) 453-3200
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Spinal intervertebral body fixation orthosis |
|---|---|
| Common/Usual Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Product Classification: | 21 CFR §888.3060, Class II |
| Product Code: | KWQ |
| Proprietary Name: | C-TEK C-Thru Anterior Cervical Plate System |
PREDICATE DEVICE
Predicate device information is included in this premarket notification.
INDICATIONS-FOR-USE
The C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.
DEVICE DESCRIPTION
The C-TEK C-Thru Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole or slotted hole design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
NOTE: This device system is intended for anterior cervical intervertebral body fusion only.
COMPARISON TO THE PREDICATE DEVICE
Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the C-TEK C-Thru Anterior Cervical Plate is considered substantially equivalent to the legally marketed predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to promote health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2004
Ms. Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
Re: K042798
Trade/Device Name: C-TEK C-Thru Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 7, 2004 Received: October 8, 2004
Dear Ms. Spielberger:
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. Wendy Spielberger
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to cogm finding of substantial equivalence of your device to a legally premaince notification - Messification 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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ectoral 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 H. Wilkerson
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
3
Indications for Use
510(k) Number (if known):
C-TEK C-Thru Anterior Cervical Plate System Device Name:
Indications-For-Use:
The INTERPORE CROSS C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millere
- Restorative. and Neurological Devices
510(k) Number.
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