SBI ARTFIX

K071656 · Small Bone Innovations, Inc. · HWC · Aug 27, 2007 · Orthopedic

Device Facts

• Record ID: K071656
• Device Name: SBI ARTFIX
• Applicant: Small Bone Innovations, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi ArtFIX is intended for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Device Story

SBi ArtFIX is a cannulated, fully threaded, headless compression screw system used for internal bone fixation. The device features a conical design, a cutting tip, and three distinct thread configurations along its length. It is intended for use by surgeons in clinical settings for procedures including bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture repair. The screw provides mechanical compression to stabilize bone segments, facilitating healing and structural support. The device is implanted during surgical procedures; it is a permanent or temporary fixation implant depending on clinical requirements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Ti-6Al-4V per ISO 5832-3. Design: Cannulated, fully threaded, headless compression screw with conical geometry, cutting tip, and three thread configurations. Energy source: None (mechanical).

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

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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K07/656

## 510(k) Summary

## AUG 2 7 2007

| Manufacturer: | Small Bone Innovations International, SA<br>Z.A. Les Bruyeres<br>Peronnas France 01960 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067 |
| Proprietary Name: | SBi ArtFIX |
| Classification name: | Class II, 888.3040 - Screw, Fixation, Bone |
| Common/Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Product Code: | HWC |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBi<br>ArtFIX to be substantially equivalent to other legally<br>marketed devices. |
| Device Description: | The SBi ArtFIX System consists of compression screws<br>that are used for internal fixation. ArtFIX is a cannulated,<br>fully threaded, headless compression screw based on a<br>conical design. The ArtFIX screw has a cutting tip and<br>three thread configurations along its length. |
| Intended Use: | The SBi ArtFIX is intended for bone reconstruction,<br>osteotomy, arthrodesis, joint fusion, fracture repair, and<br>fracture fixation of bones appropriate for the size of the<br>device. |
| Material: | The implants are made from Ti-6Al-4V per ISO 5832-3 |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 2 7 2007

Re: K071656 Trade/Device Name: SBi ArtFIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 23, 2007 Received: May 29, 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, 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

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Page 2 - Mr. Robert Hoehn

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.

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Barbara Buchner

Mark N. Më lkerson 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:

Device Name: SBi ArtFIX

Indications For Use:

The SBi ArtFIX is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device.

Prescription Use V (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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Barbara Bonchm

Division of General, Restorative, and Neurological Devices

**510(k) Number** *K071686*