(71 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal implant, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for temporary stabilization and aid in spinal fusions for various conditions like degenerative disc disease, trauma, and tumors, which are therapeutic medical purposes.
No
The device, KINETIC™ Anterior Cervical Plate, is described as an implant for spinal fusion and stabilization, not for diagnosing conditions. Its function is to provide temporary stabilization during the development of fusions for various spinal conditions, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it consists of physical components (bone plates, screws, and screw locking tabs) made of titanium alloy, which are hardware.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The KINETIC™ Anterior Cervical Plate is a physical implant designed for the temporary stabilization of the spine during fusion. It is a surgical device, not a diagnostic test performed on samples.
The provided information clearly describes a surgical implant used for structural support, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The KINETIC™ Anterior Cervical Plate is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with:
- Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
- Spondylolisthesis
- Trauma (including fractures or dislocations);
- Spinal cord stenosis;
- Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis);
- Tumors;
- Pseudarthrosis;
- Failed previous fusions.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The KINETIC™ Anterior Cervical Plate consists of various sizes of anterior cervical bone plates, screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The KINETIC™ Anterior Cervical Plate components will be supplied clean and "NON-STERILE".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2 to T1
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)
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
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.
NEO™ Anterior Cervical Plate System K040844
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.
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Image /page/0/Picture/0 description: The image shows the logo for "Life Spine". The words are in a bold, sans-serif font. There is a curved line underneath the word "Spine", and a registered trademark symbol to the right of the word.
K06243
Special 510(k) Summary of Safety and Effectiveness
| Special 510(k) Summary - KINETICTM Anterior Cervical Plate | |
|---|---|
| -- | ------------------------------------------------------------ |
| Submitted By: | Life Spine
2400 Hassell Road, Suite 370
Hoffman Estates, IL 60169 | NOV 16 2006 |
|----------------------|----------------------------------------------------------------------------------------|-------------|
| | Telephone: 847-884-6117
Fax: 847-884-6118 | |
| 510(k) Contact: | Erin Malloy
Life Spine
2400 Hassell Road, Suite 370
Hoffman Estates, IL 60169 | |
| Date Prepared: | September 5, 2006 | |
| Trade Name: | KINETIC™ Anterior Cervical Plate | |
| Common Name: | Spinal Fixation System | |
| Classification: | Spinal Invertertebral Body Fixation Orthosis
CFR 888.3060
Class II | |
| Device Product Code: | KWQ | |
| Predicate Device: | NEO™ Anterior Cervical Plate System K040844 and other
predicate devices | |
Device Description:
The KINETIC™ Anterior Cervical Plate consists of various sizes of anterior cervical bone plates, screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The KINETIC™ Anterior Cervical Plate components will be supplied clean and "NON-STERILE".
Intended Use of the Device:
The KINETIC™ Anterior Cervical Plate is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with:
- Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
-
- Spondylolisthesis
-
- Trauma (including fractures or dislocations);
1
Life
-
- Spinal cord stenosis;
- Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 5.
-
- Tumors;
-
- Pseudarthrosis;
-
- Failed previous fusions.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Material:
The KINETIC™ Anterior Cervical Plate is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI).
Performance Data:
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Substantial Equivalence:
The KINETIC™ Anterior Cervical Plate was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 16 2006
Life Spine % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195
Re: K062643
Trade/Device Name: KINETIC™ Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 13, 2006 Received: October 17, 2006
Dear Ms. Malloy:
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. Erin Malloy
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 vours.
POR
Mark N. Melkerson
Director Division of General, Restorative, and Neurologic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) number (if known): K062643
Device Name: KINETIC™ Anterior Cervical Plate
The KINETIC™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); tumors; pseudarthrosis; and / or failed previous fusions.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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)
Poh
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k number K062643