K Number
K073479
Device Name
KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
Date Cleared
2008-01-09

(29 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KINETIC®-SL 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 fusion in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions. Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Device Description
The KINETIC® -SL Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates and screws. 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. KINETIC®-SL Anterior Cervical Plate System components will be supplied clean and "NON-STERILE".
More Information

K062643, K07028

K062643, K07028

No
The device description and intended use focus solely on the mechanical components of a cervical plate system and do not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is described as a "KINETIC®-SL Anterior Cervical Plate System" intended for "anterior interbody screw fixation of the cervical spine" to achieve "temporary stabilization" and "cervical spinal fusion". These functions are direct interventions aimed at treating medical conditions such as "Degenerative disc disease", "Spondylolisthesis", "Trauma", "Spinal cord stenosis", "Deformity or curvatures", "Tumors", "Pseudarthrosis", and "Failed previous fusions". Such direct medical interventions for treating disease or injury classify it as a therapeutic device.

No

The description explicitly states the device is an "Anterior Cervical Plate System" intended for "anterior interbody screw fixation" and "temporary stabilization of the anterior spine" during cervical spinal fusion. This indicates it is a surgical implant used for treatment, not for diagnosing conditions.

No

The device description explicitly states that the system consists of bone plates and screws manufactured from titanium alloy, which are 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 examine specimens 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®-SL Anterior Cervical Plate System is a surgical implant intended for the physical stabilization of the cervical spine during fusion. It is a mechanical device used within the body, not for testing samples outside the body.

The provided information clearly describes a surgical implant for spinal fixation, which falls under the category of medical devices used for treatment and structural support, not for diagnostic testing of biological samples.

N/A

Intended Use / Indications for Use

The KINETIC®-SL 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 fusion in patients with (1) degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) trauma (including fractures or dislocations), (4) spinal cord stenosis, (5) deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis), (6) turnors, (7) pseudarthrosis, (8) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Product codes

KWQ

Device Description

The KINETIC® -SL Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates and screws. 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. KINETIC®-SL Anterior Cervical Plate System 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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K062643, K07028

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

K073479

Page 1 of 2

JAN - 9 2008

510(k) Summary

510(k) Summary - KINETIC®-SL Anterior Cervical Plate System

| Submitted By: | Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Rebecca Brooks
Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | December 10, 2007 |
| Trade Name: | KINETIC®-SL Anterior Cervical Plate System |
| Common Name: | Spinal Fixation System |
| Classification: | Spinal intervertebral body fixation orthosis
21 CFR 888.3060
Class II |
| Device Product Code: | KWQ |
| Predicate Device: | KINETIC® Anterior Cervical Plate K062643
Life Spine Anterior Cervical Plate System K07028 |

Device Description:

The KINETIC® -SL Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates and screws. 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. KINETIC®-SL Anterior Cervical Plate System components will be supplied clean and "NON-STERILE".

1

K073479

Page 2 of 2

Intended Use of the Device:

The KINETIC®-SL 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 fusion in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);

(2) Spondylolisthesis

(3) Trauma (including fractures or dislocations);

(4) Spinal cord stenosis;

(5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);

(6) Tumors:

(7) Pseudarthrosis;

(8) Failed previous fusions.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine,

Substantial Equivalence:

The KINETIC® SL Anterior Cervical Plate System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

2

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Life Spine % Ms. Rebecca Brooks 2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169

Re: K073479

Trade/Device Name: KINETIC®-SL Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 10, 2007 Received: December 11, 2007

Dear Ms. Brooks:

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.

3

Page 2 - Ms. Rebecca Brooks

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark M. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Image /page/4/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is present below the word "Spine". The logo is simple and modern.

Page 1 of 1

Indications for Use

510(k) number (if known): _ KO73479

Device Name: KINETIC®-SL Anterior Cervical Plate System

The KINETIC® SL 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 fusion in patients with (1) degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) trauma (including fractures or dislocations), (4) spinal cord stenosis, (5) deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis), (6) turnors, (7) pseudarthrosis, (8) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

WARNING: This device is not approved for screw attachment 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)

Barbara Buehm

Division of General, Restorative, and Neurological Devices

510(k) Number K07 3179