EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM

K090415 · Eminent Spine · KWQ · Jun 1, 2009 · Orthopedic

Device Facts

• Record ID: K090415
• Device Name: EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
• Applicant: Eminent Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Device Story

Spinal buttress plate system; includes plates (24mm, 27mm) with 8° bend and two fangs to prevent rotation; includes 5.5mm screws (20mm, 25mm). Used in thoracolumbar to S1 spinal fusion procedures to maintain position of allograft/autograft bone graft material. Not for load-bearing. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of graft material to prevent migration or expulsion.

Clinical Evidence

Bench testing only.

Technological Characteristics

Buttress plate system; includes plates with 8° bend and anti-rotation fangs; 5.5mm diameter screws. Non-load bearing design. No software or electronic components.

Indications for Use

Indicated for use in spinal fusion procedures of the thoracolumbar to S1 spinal region to maintain the relative position of allografts or autografts. Used in conjunction with traditional rigid fixation. Not for load-bearing applications.

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

• MacroPore OS Spinal System (K010911)

Submission Summary (Full Text)

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K090415
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### Eminent Spine Fang Plate System

### Premarket Notification

| SUBMITTED BY | Eminent Spine<br>16001 Ronald Reagan Blvd<br>Leander, TX 78641 | |
|--------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | Pending | JUN - 1 2009 |
| OWNER/OPERATOR<br>NUMBER | 10028153 | |
| CONTACT PERSON | Primary<br>Dave Freehill<br>President/Co-Founder<br>Phone: [phone]<br>Fax: [phone] | Alternate<br>Steve Courtney, M.D.<br>President/Co-Founder<br>Phone: [phone]<br>Fax: [phone] |
| SUBMISSION PREPARED BY | Lisa Peterson<br>QA Consulting, Inc.<br>Phone: [phone] | |
| DATE PREPARED | February 13, 2009 | |
| CLASSIFICATION NAME | KWQ 888.3060- Spinal Intervertebral Body Fixation Orthosis | |
| COMMON NAME | Buttress Plate | |
| PROPRIETARY NAME | Eminent Spine Fang Plate System | |
| PREDICATE DEVICE(S) | MacroPore OS Spinal System (K010911) | |
| SUBSTANTIAL EQUIVALENCE | | |

The Eminent Spine Fang Plate System was determined to be substantially equivalent to the MacroPore OS Spinal System (K010911).

### DEVICE DESCRIPTION

The Eminent Spine Fang Plate System consists of a plate and screw. The plate, which is available in two sizes (24nm and 27mm), is designed with an 8° bend to conform to the anatomy of the anterior spine to prevent migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Additionally, the plate features two "fangs" that prevent rotation, and a screw slot for final fixation. The 5.5mm screws are available in 20mm and 25mm lengths.

## INDICATIONS:

The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

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K090415
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# MECHANICAL TEST DATA

Mechanical test results demonstrate that the Eminent Spine Fang Plate System is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eminent Spine % Mr. Dave Freehill President/Co-Founder 16001 Ronald Reagan Boulevard Leander. Texas 78641

JUN - 1 2009

Re: K090415

Trade/Device Name: Eminent Spine Fang Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: May 13, 2009 Received: May 14, 2009

Dear Mr. Freehill:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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Page 2-Mr. Freehill

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchner

Mark N. Mel kerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090415

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## INDICATIONS FOR USE

510(k) Number (if known): 12090415

Device Name:

Eminent Spine Fang Plate System

Indications for Use:

The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

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)

1,096415

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hui Hui

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number.