SBI AUTOFIX

K052576 · Small Bone Innovations, LLC · HWC · Nov 7, 2005 · Orthopedic

Device Facts

• Record ID: K052576
• Device Name: SBI AUTOFIX
• Applicant: Small Bone Innovations, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBI AutoFix™ implants are primarily intended for permanent implantation in these areas: scaphoid fractures,carpal fractures and fusions, metacarpal fractures and osteotomies, distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, periarticular phalangeal fractures, metatarsal fractures and osteotomies, tarsal fusions, tarsal fractures, malleolar fractures, patellar fractures, osteochondral fractures, talo-navicular fusions, tibeo-talar fusions, cuboid fusions.

Device Story

SBI AutoFix™ System consists of cannulated and non-cannulated bone screws of varying lengths and diameters; used for internal fixation of small bone fractures, fusions, and osteotomies. Implants are permanent; manufactured from stainless steel or titanium. Device is used by surgeons in clinical settings to provide mechanical stabilization of bone segments. Output is the physical fixation of bone fragments, facilitating healing and structural stability. Benefits include restoration of bone alignment and support for functional recovery.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Cannulated and non-cannulated bone screws; materials: stainless steel and titanium; mechanical fixation device.

Indications for Use

Indicated for treatment of fractures, non-unions, pseudoarthrosis, degenerative changes, and corrective osteotomies in small bones to achieve functionally stable osteosynthesis.

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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K052576 p4/1

NOV - 7 2005

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## 510(k) Summary

| Manufacturer: | Small Bone Innovations International S.A.<br>ZA Les Bruyeres<br>01960 Peronnas<br>France |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Donald W. Guthner, Vice President<br>Musculoskeletal Clinical Regulatory Advisers<br>505 Park Avenue, 14th Floor<br>New York, NY 10022<br>[e-mail]<br>212-586-0250 - Office<br>212-750-2112 - Fax |
| Proprietary Name: | SBI AutoFix™ System |
| Classification name: | Class II, 888.3040 - Screw, Fixation, Bone, Non-Spinal |
| Common/Usual Name: | Internal Fixation Device |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI<br>AutoFix™ System to be substantially equivalent to other<br>legally marketed devices. |
| Device Description: | The SBI AutoFix™ System consists of a series of<br>Cannulated and Non-Cannulated bone screws varying in<br>length and diameter. The SBI AutoFix™ System is<br>intended for use on selected fractures in the body as<br>medically indicated and bone mass compatible. |
| Intended Use: | The SBI AutoFix™ implants are primarily intended for<br>permanent implantation in these areas: scaphoid<br>fractures,carpal fractures and fusions, metacarpal fractures<br>and osteotomies, distal radius fractures (articular<br>fragments), ulnar styloid fractures, radial head fractures,<br>capitellum fractures, humeral head fractures, glenoid<br>fractures, intercarpal distal and proximal fusions,<br>periarticular phalangeal fractures, metatarsal fractures and<br>osteotomies, tarsal fusions, tarsal fractures, malleolar<br>fractures, patellar fractures, osteochondral fractures, talo-<br>navicular fusions, tibeo-talar fusions, cuboid fusions. |
| Material: | Available in stainless steel and titanium |

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Public Health Service

NOV - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Small Bone Innovations, LLC c/o Donald Guthner, Vice President Musculoskeletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022

Re: K052576

Trade/Device Name: SBI AutoFix" System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 15, 2005 Received: September 19, 2005

Dear Mr. Guthner:

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 - Donald Guthner, Vice President

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 yours,

So Mark N. Melkerson Acting 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 AutoFix™ System

Indications For Use:

The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.

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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Signature

sion Sign-Off) Division of General, Restorative, and Neurological Devices

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