SBI FOREFOOT SET

K063635 · Small Bone Innovations, Inc. · HWC · Aug 29, 2007 · Orthopedic

Device Facts

• Record ID: K063635
• Device Name: SBI FOREFOOT SET
• Applicant: Small Bone Innovations, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.

Device Story

SBi Forefoot Set consists of metallic screws and washers for internal bone fixation. Used in hand and foot surgery following trauma or osteotomy. Implants are non-sterile and available in various sizes/configurations. Operated by surgeons in clinical settings to stabilize bone segments, facilitating healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: 316LS stainless steel (ASTM F138) or Ti6AL4V titanium (ASTM F136). Mechanical fixation device. Non-sterile.

Indications for Use

Indicated for patients requiring bone fixation of the hand and foot following trauma or osteotomy.

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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## K063635 of I PA

## 510(k) Summary

## AUG 2 9 2007

| Manufacturer: | Small Bone Innovations<br>1711 S. Pennsylvania Avenue<br>Morrisville, PA 19067 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations<br>James O' Connor<br>1711 South Pennsylvania Avenue<br>Morrisville, PA 19067<br>Phone [phone] ext 254<br>Fax [phone] |
| Proprietary Name: | SBI Forefoot Set |
| Classification name: | Class II, 888.3040- Screw, Fixation, Bone |
| Product Code: | HWC |
| Common/Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI<br>Forefoot set to be substantially equivalent to other legally<br>marketed devices. |
| Device Description: | The SBi Forefoot Set consists of screws and washers that<br>provide internal fixation of bones. The devices are<br>supplied non-sterile and are available in various sizes and<br>configurations. |
| Indications for Use: | The SBi Forefoot Set is indicated for bone fixation of the<br>hand and foot following trauma or osteotomy. |
| Material: | The implants are made from implant grade 316LS<br>stainless steel (ASTM F138) or Ti6AL4V implantable<br>Titanium (ASTM F136). |

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Small Bone Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Robert Hoehn Regulatory Associate 505 Park Avenue, 14th Floor New York, New York 10022

AUG 2 9 2007

Re: K063635

Trade/Device Name: SBi Forefoot Set Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 16, 2007 Received: July 17, 2007

Dear Mr. Hoehn:

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, JFDA 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. Robert Hoehn

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 legal]y marketed predicate device results in a classification for your device and thus, perroits 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.http://

Sincerely yours,

Barbara Buchner

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: 长巴6 3 635

Device Name: SBi Forefoot Set

Indications for Use:

The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Alvarez Buchelin

(Divis Division of General, Restorative, and Neurological Devices

510(k) Number K063635