X-VOID, SPIDER

K072198 · Sintea Biotech, Inc. · HRX · Jun 6, 2008 · Orthopedic

Device Facts

• Record ID: K072198
• Device Name: X-VOID, SPIDER
• Applicant: Sintea Biotech, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPIDER™ is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

Device Story

SPIDER™ system is a manual surgical instrument set for spinal procedures. Components include a distal expandable tamp, cannulated gauge, awl, guide wires, and reamer. The expandable tamp, constructed of Nitinol, is inserted into the spine to compress cancellous bone and create a cavity. The device is operated by a surgeon in a clinical setting. Following cavity creation, the system is used in conjunction with FDA-cleared PMMA bone cement to stabilize the fracture. The device provides a mechanical means to facilitate cement delivery, potentially reducing pain and restoring structural integrity in patients with vertebral compression fractures.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical tests were performed to verify that the device meets functional and performance specifications.

Technological Characteristics

Manual orthopedic surgical instrument. Expandable tamp component made of biocompatible Nitinol. System includes cannulated gauge, awl, guide wires, and reamer. Non-powered, mechanical operation. No software or electronic components.

Indications for Use

Indicated for patients with spinal pathological compression fractures resulting from osteoporosis, benign lesions, or malignant lesions requiring cavity creation in cancellous bone for subsequent PMMA bone cement delivery.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Kyphx® (K041454)

Submission Summary (Full Text)

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072198

## JUN - 6 2008

### Spider Spinal System 510(k) Summary

- I. Sintea Biotech, Inc. Company: 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 [phone]

| II. | Proprietary Trade Name: | Xvoid™<br>SPIDER™ |
|-----|------------------------------------------|-------------------------------------------------------------|
| | Regulation Number: | 21 CFR 888.4540<br>21 CFR 888.4200 |
| | Regulation Name: | Orthopedic manual surgical instrument.<br>Cement dispenser. |
| | Product Code:<br>Secondary Product Code: | HXG<br>OAR |

#### III. Product Description

The Sintea Biotech's SPIDER™ expandable tamp is designed to compress cancellous bone as it expands. The SPIDER™ consist of a controlled expanding tamp at the distal end, a cannulated gauge, an awl, guided wires, and a reamer. The product has the same intended use as the predicate. The expandable tamp is made out of biocompatible Nitinol metal.

#### IV. Indications

The SPIDER 110 is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

#### V. Performance Data

There is no set standard of testing for this type of device. Sintea Biotech has performed mechanical tests to verify the device meets the functional and performance specifications it was designed for. Please see section 18 of this 510(k) submission for detailed test and results.

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### VI. Substantial Equivalence

The SPIDER™ expandable bone tamps are substantially equivalent to currently marketed bone tamps with regards to intended use, function and performance, in particular with the Kyphx® from Kyphon, Inc., K041454

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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and 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 fashion around the eagle. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sintea Biotech, Inc. % Mr. Gustavo A. Rios 407 Lincoln Rd, Suite 10L Miami Beach, Florida 33139

JUN - 6 2008

Re: K072198

Trade/Device Name: Spider™ System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, OAR Dated: May 12, 2008 Received: May 28, 2008

Dear Mr. Rios:

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 - Mr. Gustavo Rios

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

Sincerely yours,

Mark M. Mullison

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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# Indications for Use

510(k) Number (if known): K072198

Device Name: SPIDERIA

Indications for Use:

The SPIDER™ is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Neil R. Posh for mrm

Division of General, Restorative, and Neurological Devices

510(k) Number K072198