BLACK WIDOW ANTERIOR BUTTRESS PLATE

K081770 · Omni Surgical, L.P. · KWQ · Apr 2, 2009 · Orthopedic

Device Facts

• Record ID: K081770
• Device Name: BLACK WIDOW ANTERIOR BUTTRESS PLATE
• Applicant: Omni Surgical, L.P.
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing applications.

Device Story

The Black Widow Anterior Buttress Plate is a low-profile spinal fixation device used in spinal fusion procedures. It is designed to prevent migration or expulsion of allograft or autograft bone material in the thoracolumbar to S1 region. The system consists of a plate shaped to conform to anterior spine anatomy, featuring two pegs that engage the vertebral body to prevent rotation, and a self-tapping screw that sits flush with the plate surface. The device is used by surgeons in a clinical setting to provide stabilization and buttressing of tissue; it is explicitly not intended for load-bearing. By maintaining the position of bone grafts, the device supports the fusion process.

Clinical Evidence

Bench testing only. Mechanical testing was conducted in accordance with ASTM F1717 to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Manufactured from Ti6Al4V per ASTM F136. Low-profile plate design with two vertebral-engaging pegs and self-tapping screws. Mechanical testing performed per ASTM F1717.

Indications for Use

Indicated for use in spinal fusion procedures to maintain the relative position of weak bony tissue (e.g., allografts) in the thoracolumbar to S1 spinal region, in conjunction with traditional rigid fixation. Not intended 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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K081770
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# 510(k) Summary Black Widow Anterior Buttress Plate

APR - 2 2009

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Black Widow Anterior Buttress Plate

Date Prepared: June 18, 2008

- 1. Submitter: Omni Surgical, LP 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746
Contact Person: Joshua Kaufman Spine 360 5000 Plaza on the Lake. Suite 305 Austin, TX 78746 Telephone: [phone]

- 2. Trade name: Black Widow Anterior Buttress Plate Common Name: Buttress plate Classification Name: Spinal intervertebral body fixation orthosis Class II 21 CFR 888 3060 KWQ
- 3. Predicate or legally marketed devices which are substantially equivalent: The Black Widow Anterior Buttress Plate is substantially equivalent to the MacroPore OS Spinal System (K010911).

#### Description of the device: ধ:

The Black Widow Anterior Buttress Plate is designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Specific system features include:

- Plate uniquely shaped to conform to anterior spine anatomy. .
- . Two peas which engage the vertebral body and prevent rotation.
- An extremely low profile plate with a full radius around the perimeter and a screw . that sits flush with the anterior surface of the staple.
- A self-tapping screw in multiple lengths. .

### Materials:

The devices are manufactured from Ti6Al4V per ASTM F136.

### Function:

The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

- ട. Intended Use:
The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing.

- 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
The Black Widow Anterior Buttress Plate is similar in terms of design and intended use as the MacroPore OS Spinal System cleared via K010911.

#### 7. Summary of Nonclinical Tests

Mechanical test results, conducted in accordance with ASTM F1717, demonstrate that the Black Widow Anterior Buttress Plate System is substantially equivalent to the predicate device.

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/1/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" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the people of the United States.

Omni Surgical, LP % Mr. Joshua Kaufman 5000 Plaza on the Lake, Suite 305 Austin Texas, 78746

APR - 2 2009

Re: K081770

Trade/Device Name: Black Widow Anterior Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 13, 2009 Received: February 19, 2009

Dear Mr. Kaufman:

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 (OS) 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 - Mr. Joshua Kaufman

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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jarbare Buehm

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

Enclosure

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K081770
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# Indications for Use

KD 81770 510(k) Number (if known):

Black Widow Anterior Buttress Plate System Device Name: ___

Indications for Use:

The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing applications.

Prescription Use _ × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

li

Claibare Bauelin

Division of General, Restorative, and Neurological Devices

**510(k) Number** *K081270*