WINDOW CERVICAL DYNAMIC PLATE SYSTEM

K993066 · Advanced Spine Technology, Inc. · KWQ · Jun 7, 2000 · Orthopedic

Device Facts

• Record ID: K993066
• Device Name: WINDOW CERVICAL DYNAMIC PLATE SYSTEM
• Applicant: Advanced Spine Technology, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Window Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, 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

Device Story

Window Cervical Dynamic Plate System; anterior cervical spinal fixation implant. System comprises titanium plates and screws; used for temporary stabilization during cervical fusion. Implanted via anterior approach by surgeons. Provides mechanical support to spine; facilitates fusion process. Non-sterile, single-use device.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing conducted per ASTM F1717 to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Materials: Titanium (ASTM F136 for Ti 6Al-4V ELI). Components: Plates of various lengths, 4mm screws, 4.3mm revision screws. Principle: Spinal intervertebral body fixation orthosis. Sterilization: Non-sterile, single-use.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization during fusion. Applicable for degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, and failed previous fusions. Contraindicated for posterior element (pedicle) fixation.

Regulatory Classification

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.

Predicate Devices

• ORION Anterior Cervical Plate System

Submission Summary (Full Text)

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K993α6i

# Section 7 - 510(k) Summary of Safety and Effectiveness

| 7.1<br>Statement | This summary of 510(k) safety and effectiveness information is being submitted<br>in accordance with the requirements of SMDA 1990 and CFR 807.92 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2<br>Submitter | Advanced Spine Technology, Inc.<br>3645 Grand Avenue, Suite 304<br>Oakland, CA. 94610 |
| 7.3<br>Company<br>Contact | Susan Finneran<br>QA/ RA Manager (Endius, Inc.)<br>508-643-0983<br>Acting as a consultant to Advanced Spine Technology, Inc. |
| 7.4<br>Device Name | Proprietary Name:<br>Window Cervical Dynamic Plate System<br>Common Name:<br>Anterior Cervical Plating System<br>Classification Name:<br>Spinal Intervertebral Body Fixation Orthosis.(KWO) |

| 7.5<br>Predicate<br>Legally<br>Marketed<br>Devices | ORION Anterior Cervical Plate System manufactured by Sofamor Danek<br>(Memphis, TN.) |
|----------------------------------------------------|--------------------------------------------------------------------------------------|
|----------------------------------------------------|--------------------------------------------------------------------------------------|

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| 7.6<br>Device<br>Description | The Window Cervical Plate System is a set of implants designed to be<br>implanted via an anterior approach to the cervical spine. The system includes<br>various plates and screws manufactured from Titanium. The material used in<br>the manufacture of the components in the Window Cervical System meets<br>ASTM F136 for Ti 6A1-4VELI. |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.7<br>Device<br>Indications and<br>Intended use | The Window Cervical Plate System is intended for anterior interbody screw<br>fixation of the cervical spine. The system is indicated for use in the<br>temporary stabilization of the anterior spine during the development of<br>cervical spinal fusions in patients with degenerative disc disease (as defined |

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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, 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

7.8 The Window Cervical Plate Spinal System is substantially equivalent to the Substantial ORION Cervical Spinal System. Equivalence Following is a table that describes the features of the new and the predicate systems that indicate substantial equivalence. Testing was also completed as per ASTM F1717 in order to demonstrate equivalence. The results of testing are included in appendix 1 of the submission.

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K993066

## 7.9 Table of Substantial Equivalence

:

| Device Name | The Window Cervical Plate Spinal System | ORION Cervical Plate System |
|-----------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Product<br>Components | Plates of various lengths, 4mm screws, 4.3mm revision screws | Plates of various lengths, 4mm screws, 4.35mm revision screws |
| Indications for Use | See above | Identical |
| Materials | Titanium | Titanium |
| Product Labeling | Instructions for use and box labeling including all of the necessary warning statements | Instructions for use and box labeling including all of the necessary warning statements |
| Packaging/<br>Sterilization | Non-sterile, single use only | Non-sterile, single use only |

Applicant Susan Jinn

Date 12/13/99

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above three wavy lines.

Public Health Service

JUN - 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gordon Tao President of Advanced Spine Technology Incorporated C/O Ms. Susan Finneran Regulatory Affairs Consultant, AST QA/RA Manager Endius Incorporated 23 West Bacon Street Plainville, Massachusetts 02762

Re: K993066

Trade Name: Window Cervical Dynamic Plate System Regulatory Class: II Product Code: KWQ Dated: March 23, 2000 Received: April 3, 2000

Dear Mr. Tao:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. Gordon Tao

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. Kirchner.

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

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### 510(k) Number (if known): K993066

#### Device Name: Window Cervical Dynamic Plate System

#### Indications for Use:

The Window Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODE)

(Posted July 1, 1998)

(Optional Format 3-10-98)

Dame R. Lachner

(Division Sign-Off) Division of General Restorative Devices 510(k) Number 199306