METASURG SUBTALAR IMPLANT

K070441 · Metasurg · HWC · May 8, 2007 · Orthopedic

Device Facts

• Record ID: K070441
• Device Name: METASURG SUBTALAR IMPLANT
• Applicant: Metasurg
• Product Code: HWC · Orthopedic
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. The Metasurg subtalar implants are intended for single use only.

Device Story

Metasurg Subtalar Implant is a one-piece titanium device implanted into the sinus tarsi of the foot. It functions as a mechanical block to prevent excessive talar displacement, thereby stabilizing the subtalar joint while permitting normal motion. The device is available in 6 sizes (7mm–12mm diameter). It is intended for surgical use by a physician to treat hyperpronated foot and associated sequelae. The implant provides structural support to correct foot mechanics and improve patient mobility.

Technological Characteristics

One-piece subtalar arthrorisis implant; material: Titanium Alloy (Ti-6AL-4V ELI); sizes: 7mm–12mm diameter; mechanical fixation; single-use.

Indications for Use

Indicated for patients with hyperpronated foot requiring subtalar joint stabilization. Designed to block forward, downward, and medial talar displacement to prevent excessive pronation. Single use only.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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MAY 8 -2007

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## 510(k) Summary

| Date Prepared: | February 14, 2007 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Metasurg<br>16350 Park Ten Place, Suite 101<br>Houston, TX 77084 |
| Company Contact: | Larry Weatherford<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | Metasurg Subtalar Implant |
| Classification Name: | Smooth & threaded metallic bone fixation fasteners (21 CFR<br>888.3040, Product Code HWC, Class II) |
| Common Name: | Subtalar Arthrorisis Implant |
| Substantial Equivalence: | Documentation is provided which demonstrates the Metasurg<br>Subtalar Implant to be substantially equivalent to other legally<br>marketed devices. |
| Device Description: | The Metasurg Subtalar Implant is a one-piece device made of<br>titanium intended to be implanted into the sinus tarsi of the foot.<br>The implant is offered in 6 sizes ranging from 7mm - 12mm in<br>diameter. The implant is used in the treatment of excessive<br>motion of the talus relative to the calcaneus. |
| Intended Usage: | The Metasurg Subtalar Implant is indicated for use in the<br>treatment of the hyperpronated foot and stabilization of the<br>subtalar joint. It is designed to block forward, downward and<br>medial displacement of the talus, thus allowing normal subtalar<br>joint motion but blocking excessive pronation and the resulting<br>sequela.<br>The Metasurg subtalar implants are intended for single use only. |
| Material: | Titanium Alloy (Ti-6AL-4V ELI) |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

2007 MAY 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Metasurg % Mr. Larry Weatherford Vice President 16350 Park Ten Place, Suite 101 Houston, Texas 77084

Re: K070441

Trade/Device Name: Metasurg Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 14, 2007 Received: February 16, 2007

Dear Mr. Weatherford:

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. Larry Weatherford

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 Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Sincerely, yours,

Barbara Buell

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: Pending

Device Name: Metasurg Subtalar Implant

Indications For Use:

The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

The Metasurg subtalar implants are intended for single use only.

Prescription Use V (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Darlaue Buem

and Neurolog

**510(k) Number** k070441