SBI TWISTOFIX

K071541 · Small Bone Innovations, Inc. · HWC · Sep 10, 2007 · Orthopedic

Device Facts

• Record ID: K071541
• Device Name: SBI TWISTOFIX
• Applicant: Small Bone Innovations, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Device Story

SBi TwistoFIX is a titanium bone screw system for internal fixation. Screws are machined on the end of a drill shank that inserts into a driver. Upon insertion into bone, the drill shank twists off and breaks cleanly from the screw head. Used by surgeons in clinical settings for bone reconstruction, osteotomy, and fracture repair. Provides mechanical fixation to stabilize bone segments, facilitating healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Implants made from Ti-6Al-4V per ISO 5832-3. System consists of titanium bone screws with integrated drill shanks that break off after insertion. Available in various diameters and lengths. Non-sterile supply.

Indications for Use

Indicated for bone reconstruction, osteotomy, 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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K071541

## 510(k) Summary

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## SEP 1 0 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 TwistoFIX |
| Classification name: | Class II, 888.3040 - Smooth or threaded metallic bone<br>fixation fastener |
| Common/Usual Name: | Screw, Fixation, Bone |
| Product Code: | HWC |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBi<br>TwistoFIX to be substantially equivalent to other legally<br>marketed devices. |
| Device Description: | The SBi TwistoFIX System consists of a set of titanium<br>bone screws for internal fixation. The screws are<br>machined on the end of a drill shank which inserts into a<br>driver. After insertion of the screw into the bone, the drill<br>shank twists off and breaks cleanly from the screw head.<br>The devices are supplied non-sterile and are available in<br>various sizes diameters and lengths. |
| Intended Use: | The SBi TwistoFIX is indicated for bone reconstruction,<br>osteotomy, fracture repair, and fracture fixation of bones<br>appropriate for the size of the device. |
| Material: | The implants are made from Ti-6Al-4V per ISO 5832-3 |

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SEP 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) % Small Bone Innovations International, SA Mr. Robert Hoehn Regulatory Associate 1380 S. Pennsylvania Avenue Morrisville, PA 19067

Re: K071541

Trade/Device Name: SBI TwistoFIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 5, 2007 Received: September 7, 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 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 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.html.

Sincerely yours.

Jaubere Bueher

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:

Device Name: SBi TwistoFIX

Indications For Use:

The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of 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)

Page 1 of 1

Barbara Buchro

Division of General, Restorative. and Neurological Devices

**510(k) Number** K071541